SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 1 LIGHT

Dosage form: cream
Ingredients: Octinoxate 1149mg in 60.45g, Titanium Dioxide 7556mg in 60.45g
Labeler: SHISEIDO AMERICA INC.
NDC Code: 52686-260

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 THE SKINCARE TINTED MOISTURE PROTECTION

Drug Facts

Active ingredientsPurpose
OCTINOXATE 1.9%Sunscreen
TITANIUM DIOXIDE 12.5%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
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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

WATER, CYCLOMETHICONE, GLYCERIN, DIMETHICONE, TALC, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, XYLITOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, TRIMETHYLSILOXYSILICATE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, DISTEARDIMONIUM HECTORITE, ERYTHRITOL, TREHALOSE, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, HYDROXYPROPYL CYCLODEXTRIN, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, SODIUM HYALURONATE, CITRUS JUNOS SEED EXTRACT, PHYTOSTERYL MACADAMIATE, ISOSTEARIC ACID, CALCIUM STEARATE, GLYCERYL DIISOSTEARATE, ALCOHOL, TRISODIUM EDTA, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BHT, TOCOPHEROL, PEG-60 GLYCERYL ISOSTEARATE, PHENOXYETHANOL, FRAGRANCE, 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 DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1 LIGHT

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2 MEDIUM

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3 MEDIUM DEEP

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4 DEEP

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION   1 LIGHT
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-260
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate1149 mg  in 60.45 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide7556 mg  in 60.45 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
GLYCERIN 
DIMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIPROPYLENE GLYCOL 
XYLITOL 
PEG-10 DIMETHICONE (600 CST) 
TRIMETHYLSILOXYSILICATE (M/Q 0.66) 
ALUMINUM HYDROXIDE 
ALUMINUM DISTEARATE 
ERYTHRITOL 
TREHALOSE 
THIOTAURINE 
MENTHA PIPERITA LEAF 
HYALURONATE SODIUM 
CITRUS JUNOS SEED 
ISOSTEARIC ACID 
CALCIUM STEARATE 
ALCOHOL 
EDETATE TRISODIUM 
BUTYLATED HYDROXYTOLUENE 
.ALPHA.-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:52686-260-601 TUBE in 1 CARTON
160.45 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2008
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION   2 MEDIUM
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-261
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate1149 mg  in 60.45 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide7556 mg  in 60.45 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
GLYCERIN 
DIMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIPROPYLENE GLYCOL 
XYLITOL 
PEG-10 DIMETHICONE (600 CST) 
TRIMETHYLSILOXYSILICATE (M/Q 0.66) 
ALUMINUM HYDROXIDE 
ALUMINUM DISTEARATE 
ERYTHRITOL 
TREHALOSE 
THIOTAURINE 
MENTHA PIPERITA LEAF 
HYALURONATE SODIUM 
CITRUS JUNOS SEED 
ISOSTEARIC ACID 
CALCIUM STEARATE 
ALCOHOL 
EDETATE TRISODIUM 
BUTYLATED HYDROXYTOLUENE 
.ALPHA.-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:52686-261-601 TUBE in 1 CARTON
160.45 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2008
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION   3 MEDIUM DEEP
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-262
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate1149 mg  in 60.45 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide7556 mg  in 60.45 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
GLYCERIN 
DIMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIPROPYLENE GLYCOL 
XYLITOL 
PEG-10 DIMETHICONE (600 CST) 
TRIMETHYLSILOXYSILICATE (M/Q 0.66) 
ALUMINUM HYDROXIDE 
ALUMINUM DISTEARATE 
ERYTHRITOL 
TREHALOSE 
THIOTAURINE 
MENTHA PIPERITA LEAF 
HYALURONATE SODIUM 
CITRUS JUNOS SEED 
ISOSTEARIC ACID 
CALCIUM STEARATE 
ALCOHOL 
EDETATE TRISODIUM 
BUTYLATED HYDROXYTOLUENE 
.ALPHA.-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:52686-262-601 TUBE in 1 CARTON
160.45 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2008
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION   4 DEEP
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-263
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate1149 mg  in 60.45 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide7556 mg  in 60.45 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
GLYCERIN 
DIMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIPROPYLENE GLYCOL 
XYLITOL 
PEG-10 DIMETHICONE (600 CST) 
TRIMETHYLSILOXYSILICATE (M/Q 0.66) 
ALUMINUM HYDROXIDE 
ALUMINUM DISTEARATE 
ERYTHRITOL 
TREHALOSE 
THIOTAURINE 
MENTHA PIPERITA LEAF 
HYALURONATE SODIUM 
CITRUS JUNOS SEED 
ISOSTEARIC ACID 
CALCIUM STEARATE 
ALCOHOL 
EDETATE TRISODIUM 
BUTYLATED HYDROXYTOLUENE 
.ALPHA.-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:52686-263-601 TUBE in 1 CARTON
160.45 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2008
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIOperations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-260, 52686-261, 52686-262, 52686-263), ANALYSIS(52686-260, 52686-261, 52686-262, 52686-263)
Establishment
NameAddressID/FEIOperations
Davlyn Industries Inc624436254MANUFACTURE(52686-260, 52686-261, 52686-262, 52686-263)

Revised: 06/2012
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)