SHISEIDO SUN PROTECTION FOUNDATION BEIGE

Dosage form: stick
Ingredients: OCTINOXATE 261mg in 9g, TITANIUM DIOXIDE 414mg in 9g
Labeler: SHISEIDO AMERICA INC.
NDC Code: 52686-282

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 FOUNDATION

Drug Facts

Active ingredientsPurpose
OCTINOXATE 2.9%Sunscreen
TITANIUM DIOXIDE 4.6%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

HYDROGENATED POLYDECENE, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, POLYMETHYL METHACRYLATE, KAOLIN, TRIETHYLHEXANOIN, POLYETHYLENE, SORBITAN SESQUIISOSTEARATE, MICROCRYSTALLINE WAX, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, ZINC MYRISTATE, TOCOPHERYL ACETATE, THIOTAURINE, STEARYL GLYCYRRHETINATE, COPERNICIA CERIFERA (CARNAUBA) WAX, METHICONE, SILICA, GLYCERIN, TOCOPHEROL, BHT, SODIUM CARBONATE, FRAGRANCE, MICA, 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 DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton (Beige)

SHISEIDO

37

Sun Protection
Stick Foundation
(Beige)

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31OZ.

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton (Ochre)

SHISEIDO

37

Sun Protection
Stick Foundation
(Ochre)

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31OZ.

SHISEIDO SUN PROTECTION FOUNDATION   BEIGE
octinoxate and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-282
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE261 mg  in 9 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE414 mg  in 9 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
HYDROGENATED POLYDECENE (550 MW) 
DIMETHICONE 
KAOLIN 
TRIETHYLHEXANOIN 
HIGH DENSITY POLYETHYLENE 
MICROCRYSTALLINE WAX 
ZINC MYRISTATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
THIOTAURINE 
STEARYL GLYCYRRHETINATE 
CARNAUBA WAX 
METHICONE (20 CST) 
SILICON DIOXIDE 
GLYCERIN 
.ALPHA.-TOCOPHEROL 
BUTYLATED HYDROXYTOLUENE 
SODIUM CARBONATE 
MICA 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:52686-282-201 CARTRIDGE in 1 CARTON
19 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2004
SHISEIDO SUN PROTECTION FOUNDATION   OCHRE
octinoxate and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-283
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE261 mg  in 9 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE414 mg  in 9 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
HYDROGENATED POLYDECENE (550 MW) 
DIMETHICONE 
KAOLIN 
TRIETHYLHEXANOIN 
HIGH DENSITY POLYETHYLENE 
MICROCRYSTALLINE WAX 
ZINC MYRISTATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
THIOTAURINE 
STEARYL GLYCYRRHETINATE 
CARNAUBA WAX 
METHICONE (20 CST) 
SILICON DIOXIDE 
GLYCERIN 
.ALPHA.-TOCOPHEROL 
BUTYLATED HYDROXYTOLUENE 
SODIUM CARBONATE 
MICA 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:52686-283-201 CARTRIDGE in 1 CARTON
19 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2004
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIOperations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-282, 52686-283), ANALYSIS(52686-282, 52686-283)
Establishment
NameAddressID/FEIOperations
Davlyn Industries Inc624436254MANUFACTURE(52686-282, 52686-283)

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.

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