SHISEIDO SUN PROTECTION FOUNDATION  BEIGE- octinoxate and titanium dioxide stick 
SHISEIDO SUN PROTECTION FOUNDATION  OCHRE- octinoxate and titanium dioxide stick 
SHISEIDO AMERICA INC.

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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 (Beige)

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.

Principal Display Panel - 9 g Cartridge Carton (Ochre)
SHISEIDO SUN PROTECTION FOUNDATION   BEIGE
octinoxate and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-282
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE261 mg  in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE414 mg  in 9 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ZINC MYRISTATE (UNII: K09A9E2GGO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
THIOTAURINE (UNII: NQZ2D7AO62)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-282-201 in 1 CARTON01/01/200401/31/2017
19 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02001/01/200401/31/2017
SHISEIDO SUN PROTECTION FOUNDATION   OCHRE
octinoxate and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-283
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE261 mg  in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE414 mg  in 9 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ZINC MYRISTATE (UNII: K09A9E2GGO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
THIOTAURINE (UNII: NQZ2D7AO62)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-283-201 in 1 CARTON01/01/200401/31/2017
19 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02001/01/200401/31/2017
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-282, 52686-283) , ANALYSIS(52686-282, 52686-283)
Establishment
NameAddressID/FEIBusiness Operations
Davlyn Industries Inc624436254MANUFACTURE(52686-282, 52686-283)

Revised: 10/2023
 
SHISEIDO AMERICA INC.