Your browser does not support JavaScript! SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER (OCTINOXATE) LIPSTICK [SHISEIDO AMERICA INC.]
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SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER (octinoxate) lipstick
[SHISEIDO AMERICA INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

ACTIVE INGREDIENT

OCTINOXATE 4.9%

Purpose

Sunscreen

Use

  • helps prevent sunburn

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:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor

Inactive Ingredients

POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, MACADAMIA TERNIFOLIA SEED OIL, POLYETHYLENE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, MICROCRYSTALLINE WAX, EUPHORBIA CERIFERA (CANDELILLA) WAX, WATER, SODIUM MAGNESIUM SILICATE, GLYCERIN, ARGININE HCl, XYLITOL, TOCOPHERYL ACETATE, ALLANTOIN, SODIUM HYALURONATE, PEG-10 DIMETHICONE, TOCOPHEROL, DIMETHICONE, DIISOSTEARYL MALATE, BHT, METHICONE, TETRADECENE, SILICA, POLYSILICONE-2, 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 - 4g Cartridge Carton

SHISEIDO

The Skincare

Protective
Lip Conditioner
SPF 12
SUNSCREEN

4g NET WT. .14 OZ.

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton
SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52686-134
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE196 mg  in 4 g
Inactive Ingredients
Ingredient NameStrength
TRIISOSTEARIN 
MACADAMIA OIL 
HIGH DENSITY POLYETHYLENE 
DIPHENYLSILOXY PHENYL TRIMETHICONE 
TRIETHYLHEXANOIN 
MICROCRYSTALLINE WAX 
CANDELILLA WAX 
WATER 
GLYCERIN 
ARGININE HYDROCHLORIDE 
XYLITOL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ALLANTOIN 
HYALURONATE SODIUM 
PEG-10 DIMETHICONE (600 CST) 
.ALPHA.-TOCOPHEROL 
DIMETHICONE 
DIISOSTEARYL MALATE 
BUTYLATED HYDROXYTOLUENE 
METHICONE (20 CST) 
TETRADECENE 
SILICON DIOXIDE 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-134-201 in 1 CARTON
14 g in 1 CARTRIDGE
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(52686-134), ANALYSIS(52686-134)
Establishment
NameAddressID/FEIBusiness Operations
Davlyn Industries Inc624436254MANUFACTURE(52686-134)

Revised: 9/2012
 
SHISEIDO AMERICA INC.

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