Your browser does not support JavaScript! CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]
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CLE DE PEAU BEAUTE UV PROTECTION (octinoxate, octocrylene, oxybenzone, and zinc oxide) cream
[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 ingredientsPurpose
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
OXYBENZONE 1.5%Sunscreen
ZINC OXIDE 9.0%Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply evenly before sun exposure and as needed.
  • children under 6 months of age: ask a doctor.

Inactive Ingredients

WATER • BUTYLENE GLYCOL • ISOHEXADECANE • DIMETHICONE • ISOPROPYL MYRISTATE • GLYCERIN • POLYMETHYLSILSESQUIOXANE • SD ALCOHOL 40-B • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • PEG-6 • XYLITOL • PEG-32 • SODIUM HYALURONATE • TOCOPHERYL ACETATE • LACTOBACILLUS/HIBISCUS SABDARIFFA FLOWER FERMENT FILTRATE • CRATAEGUS MONOGYNA FLOWER EXTRACT • THIOTAURINE • DIPOTASSIUM GLYCYRRHIZATE • 2-O-ETHYL ASCORBIC ACID • SODIUM ACETYLATED HYALURONATE • POLYQUATERNIUM-51 • SAXIFRAGA SARMENTOSA EXTRACT • UNCARIA GAMBIR EXTRACT • GINKGO BILOBA LEAF EXTRACT • THYMUS SERPILLUM EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • CURCUMA LONGA (TURMERIC) ROOT EXTRACT • HYPERICUM ERECTUM EXTRACT • HYDROLYZED SILK • BUPLEURUM FALCATUM ROOT EXTRACT • HYDROGENATED POLYDECENE • SILICA • ISOSTEARIC ACID • HYDROGEN DIMETHICONE • TRISODIUM EDTA • BHT • ALCOHOL • TOCOPHEROL • PHENOXYETHANOL • FRAGRANCE • TITANIUM DIOXIDE • MICA •

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Carton

clé de peau

BEAUTÉ

SPF
50
PA+++
sunscreen

UV protection cream

50mL NET WT. 1.9 OZ.

Principal Display Panel - 50 mL Carton
CLE DE PEAU BEAUTE UV PROTECTION 
octinoxate, octocrylene, oxybenzone, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52686-259
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate4.06 g  in 54.91 g
Octocrylene (Octocrylene) Octocrylene1.65 g  in 54.91 g
Oxybenzone (Oxybenzone) Oxybenzone0.82 g  in 54.91 g
Zinc oxide (Zinc oxide) Zinc oxide4.94 g  in 54.91 g
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
ISOHEXADECANE 
DIMETHICONE 
ISOPROPYL MYRISTATE 
GLYCERIN 
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 
POLYETHYLENE GLYCOL 300 
XYLITOL 
POLYETHYLENE GLYCOL 1500 
HYALURONATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
CRATAEGUS MONOGYNA FLOWER 
THIOTAURINE 
GLYCYRRHIZINATE DIPOTASSIUM 
2-O-ETHYL ASCORBIC ACID 
SAXIFRAGA STOLONIFERA LEAF 
GINKGO 
ROSA ROXBURGHII FRUIT 
TURMERIC 
BUPLEURUM FALCATUM ROOT 
HYDROGENATED POLYDECENE (550 MW) 
SILICON DIOXIDE 
ISOSTEARIC ACID 
EDETATE TRISODIUM 
BUTYLATED HYDROXYTOLUENE 
ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
TITANIUM DIOXIDE 
MICA 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-259-601 in 1 CARTON
154.91 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-259), ANALYSIS(52686-259)
Establishment
NameAddressID/FEIBusiness Operations
Davlyn Industries Inc624436254MANUFACTURE(52686-259)

Revised: 2/2012
 
SHISEIDO AMERICA INC.

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