SHISEIDO SUN PROTECTION- octinoxate and titanium dioxide stick 
SHISEIDO AMERICAS CORPORATION

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SHISEIDO SUN PROTECTION

Drug Facts

Active ingredientsPurpose
OCTINOXATE 4.9%Sunscreen
TITANIUM DIOXIDE 9.2%Sunscreen

Uses

  • helps prevent sunburn

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, POLYMETHYL METHACRYLATE, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, BARIUM SULFATE, KAOLIN, POLYETHYLENE, SORBITAN SESQUIISOSTEARATE, MICROCRYSTALLINE WAX, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, ZINC MYRISTATE, TOCOPHERYL ACETATE, THIOTAURINE, STEARYL GLYCYRRHETINATE, COPERNICIA CERIFERA (CARNAUBA) WAX, METHICONE, SILICA, ALUMINA, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, TOCOPHEROL, BHT, SODIUM CARBONATE, FRAGRANCE, MICA, TITANIUM DIOXIDE,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton

SHISEIDO

Anti-Aging
Suncare

37

Sun Protection
Stick

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31 OZ.

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton
SHISEIDO SUN PROTECTION 
octinoxate and titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE441 mg  in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE828 mg  in 9 g
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
MICA (UNII: V8A1AW0880)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
KAOLIN (UNII: 24H4NWX5CO)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ZINC MYRISTATE (UNII: K09A9E2GGO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
THIOTAURINE (UNII: NQZ2D7AO62)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-161-201 in 1 CARTON04/01/201409/30/2020
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 DrugM02004/01/201409/30/2020
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-161) , analysis(58411-161)

Revised: 10/2023
 
SHISEIDO AMERICAS CORPORATION