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 ingredientsPurpose
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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58411-161
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE441 mg  in 9 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE828 mg  in 9 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) 
DIMETHICONE 
DIPHENYLSILOXY PHENYL TRIMETHICONE 
TRIETHYLHEXANOIN 
BARIUM SULFATE 
KAOLIN 
HIGH DENSITY POLYETHYLENE 
MICROCRYSTALLINE WAX 
ZINC MYRISTATE 
.ALPHA.-TOCOPHEROL ACETATE 
THIOTAURINE 
STEARYL GLYCYRRHETINATE 
CARNAUBA WAX 
METHICONE (20 CST) 
SILICON DIOXIDE 
ALUMINUM OXIDE 
GLYCERIN 
TRIETHOXYCAPRYLYLSILANE 
TOCOPHEROL 
BUTYLATED HYDROXYTOLUENE 
SODIUM CARBONATE 
MICA 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-161-201 in 1 CARTON
19 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/2014
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-161), ANALYSIS(58411-161)
Establishment
NameAddressID/FEIBusiness Operations
Davlyn Industries Inc624436254MANUFACTURE(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