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

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.

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SHISEIDO SUN PROTECTION

Drug Facts

Active ingredients Purpose
OCTINOXATE 4.9% Sunscreen
TITANIUM DIOXIDE 9.2% Sunscreen

Uses

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:

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:58411-161
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 441 mg  in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 828 mg  in 9 g
Inactive Ingredients
Ingredient Name Strength
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)  
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58411-161-20 1 in 1 CARTON
1 9 g in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/01/2014
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
Name Address ID/FEI Business Operations
SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-161) , ANALYSIS(58411-161)
Establishment
Name Address ID/FEI Business Operations
Davlyn Industries Inc 624436254 MANUFACTURE(58411-161)

Revised: 2/2014
Document Id: d78a1818-e592-454c-9cc0-f8d3c4d0314c
Set id: 9b3a0a99-b701-420b-8d45-cdcae332e141
Version: 1
Effective Time: 20140225
 
SHISEIDO AMERICAS CORPORATION