SHISEIDO SUN PROTECTION FOUNDATION SP10

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 1488mg in 36.3g
Labeler: SHISEIDO AMERICA INC.
NDC Code: 52686-264

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SHISEIDO SUN PROTECTION LIQUID FOUNDATION

Drug Facts

Active ingredient

TITANIUM DIOXIDE 4.1%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive Ingredients

CYCLOMETHICONE, WATER, TRIMETHYLSILOXYSILICATE, TALC, DIPROPYLENE GLYCOL, PEG/PPG-19/19 DIMETHICONE, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, ZINC MYRISTATE, TOCOPHERYL ACETATE, THIOTAURINE, STEARYL GLYCYRRHETINATE, ETHYLHEXYL METHOXYCINNAMATE, ISOSTEARIC ACID, ALUMINUM DISTEARATE, ALUMINUM HYDROXIDE, CALCIUM STEARATE, TRIETHOXYCAPRYLYLSILANE, GLYCERIN, POLYSILICONE-2, SODIUM CITRATE, TOCOPHEROL, PALMITIC ACID, DISTEARYLDIMONIUM CHLORIDE, TRISODIUM EDTA, ISOPROPYL ALCOHOL, BHT, METHYLPARABEN, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES

Other information

protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - SP10

SHISEIDO

Sun Protection
Liquid Foundation

BROAD SPECTRUM
SPF 42

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - SP20

SHISEIDO

Sun Protection
Liquid Foundation

BROAD SPECTRUM
SPF 42

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - SP30

SHISEIDO

Sun Protection
Liquid Foundation

BROAD SPECTRUM
SPF 42

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - SP40

SHISEIDO

Sun Protection
Liquid Foundation

BROAD SPECTRUM
SPF 42

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - SP50

SHISEIDO

Sun Protection
Liquid Foundation

BROAD SPECTRUM
SPF 42

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - SP60

SHISEIDO

Sun Protection
Liquid Foundation

BROAD SPECTRUM
SPF 42

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - SP70

SHISEIDO

Sun Protection
Liquid Foundation

BROAD SPECTRUM
SPF 42

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

SHISEIDO SUN PROTECTION FOUNDATION SP10
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-264
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1488 mg in 36.3 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
WATER
TITANIUM DIOXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TALC
DIPROPYLENE GLYCOL
PEG/PPG-19/19 DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
OCTINOXATE
ISOSTEARIC ACID
ALUMINUM DISTEARATE
ALUMINUM HYDROXIDE
CALCIUM STEARATE
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
GLYCERIN
SODIUM CITRATE
ZINC MYRISTATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
PALMITIC ACID
DISTEARYLDIMONIUM CHLORIDE
EDETATE TRISODIUM
STEARYL GLYCYRRHETINATE
THIOTAURINE
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE

Packaging
#	Item Code	Package Description
1	NDC:52686-264-10	1 BOTTLE in 1 CARTON
1		36.3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004

SHISEIDO SUN PROTECTION FOUNDATION SP20
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-265
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1488 mg in 36.3 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
WATER
TITANIUM DIOXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TALC
DIPROPYLENE GLYCOL
PEG/PPG-19/19 DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
OCTINOXATE
ISOSTEARIC ACID
ALUMINUM DISTEARATE
ALUMINUM HYDROXIDE
CALCIUM STEARATE
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
GLYCERIN
SODIUM CITRATE
ZINC MYRISTATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
PALMITIC ACID
DISTEARYLDIMONIUM CHLORIDE
EDETATE TRISODIUM
STEARYL GLYCYRRHETINATE
THIOTAURINE
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE

Packaging
#	Item Code	Package Description
1	NDC:52686-265-10	1 BOTTLE in 1 CARTON
1		36.3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004

SHISEIDO SUN PROTECTION FOUNDATION SP30
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-266
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1488 mg in 36.3 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
WATER
TITANIUM DIOXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TALC
DIPROPYLENE GLYCOL
PEG/PPG-19/19 DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
OCTINOXATE
ISOSTEARIC ACID
ALUMINUM DISTEARATE
ALUMINUM HYDROXIDE
CALCIUM STEARATE
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
GLYCERIN
SODIUM CITRATE
ZINC MYRISTATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
PALMITIC ACID
DISTEARYLDIMONIUM CHLORIDE
EDETATE TRISODIUM
STEARYL GLYCYRRHETINATE
THIOTAURINE
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE

Packaging
#	Item Code	Package Description
1	NDC:52686-266-10	1 BOTTLE in 1 CARTON
1		36.3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004

SHISEIDO SUN PROTECTION FOUNDATION SP40
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-267
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1488 mg in 36.3 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
WATER
TITANIUM DIOXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TALC
DIPROPYLENE GLYCOL
PEG/PPG-19/19 DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
OCTINOXATE
ISOSTEARIC ACID
ALUMINUM DISTEARATE
ALUMINUM HYDROXIDE
CALCIUM STEARATE
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
GLYCERIN
SODIUM CITRATE
ZINC MYRISTATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
PALMITIC ACID
DISTEARYLDIMONIUM CHLORIDE
EDETATE TRISODIUM
STEARYL GLYCYRRHETINATE
THIOTAURINE
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE

Packaging
#	Item Code	Package Description
1	NDC:52686-267-10	1 BOTTLE in 1 CARTON
1		36.3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004

SHISEIDO SUN PROTECTION FOUNDATION SP50
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-268
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1488 mg in 36.3 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
WATER
TITANIUM DIOXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TALC
DIPROPYLENE GLYCOL
PEG/PPG-19/19 DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
OCTINOXATE
ISOSTEARIC ACID
ALUMINUM DISTEARATE
ALUMINUM HYDROXIDE
CALCIUM STEARATE
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
GLYCERIN
SODIUM CITRATE
ZINC MYRISTATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
PALMITIC ACID
DISTEARYLDIMONIUM CHLORIDE
EDETATE TRISODIUM
STEARYL GLYCYRRHETINATE
THIOTAURINE
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE

Packaging
#	Item Code	Package Description
1	NDC:52686-268-10	1 BOTTLE in 1 CARTON
1		36.3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004

SHISEIDO SUN PROTECTION FOUNDATION SP60
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-269
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1488 mg in 36.3 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
WATER
TITANIUM DIOXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TALC
DIPROPYLENE GLYCOL
PEG/PPG-19/19 DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
OCTINOXATE
ISOSTEARIC ACID
ALUMINUM DISTEARATE
ALUMINUM HYDROXIDE
CALCIUM STEARATE
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
GLYCERIN
SODIUM CITRATE
ZINC MYRISTATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
PALMITIC ACID
DISTEARYLDIMONIUM CHLORIDE
EDETATE TRISODIUM
STEARYL GLYCYRRHETINATE
THIOTAURINE
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE

Packaging
#	Item Code	Package Description
1	NDC:52686-269-10	1 BOTTLE in 1 CARTON
1		36.3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004

SHISEIDO SUN PROTECTION FOUNDATION SP70
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-270
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1488 mg in 36.3 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
WATER
TITANIUM DIOXIDE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TALC
DIPROPYLENE GLYCOL
PEG/PPG-19/19 DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
OCTINOXATE
ISOSTEARIC ACID
ALUMINUM DISTEARATE
ALUMINUM HYDROXIDE
CALCIUM STEARATE
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
GLYCERIN
SODIUM CITRATE
ZINC MYRISTATE
.ALPHA.-TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
PALMITIC ACID
DISTEARYLDIMONIUM CHLORIDE
EDETATE TRISODIUM
STEARYL GLYCYRRHETINATE
THIOTAURINE
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE

Packaging
#	Item Code	Package Description
1	NDC:52686-270-10	1 BOTTLE in 1 CARTON
1		36.3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2004

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-264, 52686-265, 52686-266, 52686-267, 52686-268, 52686-269, 52686-270), ANALYSIS(52686-264, 52686-265, 52686-266, 52686-267, 52686-268, 52686-269, 52686-270)

Establishment
Name	Address	ID/FEI	Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-264, 52686-265, 52686-266, 52686-267, 52686-268, 52686-269, 52686-270)

Revised: 07/2012

Document Id: 4bbb3c07-5fb8-4257-a17a-f52689ae3b2f

Set id: a65ae2eb-58d8-43f4-a479-7386b6bc028b

Version: 1

Effective Time: 20120706

SHISEIDO AMERICA INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

SHISEIDO SUN PROTECTION FOUNDATION SP10

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