SHISEIDO SUN PROTECTION LIP TREATMENT- octinoxate and titanium dioxide lipstick 
SHISEIDO AMERICA INC.

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 LIP TREATMENT

Drug Facts

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 7.4%Sunscreen
TITANIUM DIOXIDE 4.5%Sunscreen

Use

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

TRIETHYLHEXANOIN, POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, HYDROGENATED POLYISOBUTENE, POLYETHYLENE, PEG/PPG-36/41 DIMETHYL ETHER, MICROCRYSTALLINE WAX, STEARYL GLYCYRRHETINATE, GLUTATHIONE, ZINC MYRISTATE, THIOTAURINE, SODIUM ACETYLATED HYALURONATE, ALUMINUM HYDROXIDE, TOCOPHEROL, DIISOSTEARYL MALATE, SODIUM MAGNESIUM SILICATE, GLYCERIN, BHT, FRAGRANCE,

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

SHI SEIDO

SPF 35

Sun Protection
Lip Treatment

SUNSCREEN

4g NET WT. .14 OZ.

Principal Display Panel - 4g Cartridge Carton
SHISEIDO SUN PROTECTION LIP TREATMENT 
octinoxate and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-642
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE296 mg  in 4 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE180 mg  in 4 g
Inactive Ingredients
Ingredient NameStrength
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
TRIISOSTEARIN (UNII: 71503RH8KG)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
GLUTATHIONE (UNII: GAN16C9B8O)  
ZINC MYRISTATE (UNII: K09A9E2GGO)  
THIOTAURINE (UNII: NQZ2D7AO62)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-642-201 in 1 CARTON10/01/2012
14 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(52686-642) , analysis(52686-642)

Revised: 12/2018
Document Id: 7cf21ffd-915c-27b9-e053-2991aa0a874d
Set id: ba1e618b-589f-4151-9e84-716a50ec8c2a
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICA INC.