Label: CLE DE PEAU BEAUTE SHEER FLUID VEIL- avobenzone, octinoxate, and octocrylene cream
- NDC Code(s): 58411-206-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 13, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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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
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
WATER∙SD ALCOHOL 40-B∙BUTYLENE GLYCOL∙XYLITOL∙DIMETHICONE∙TALC∙GLYCERIN∙POLYMETHYL METHACRYLATE∙PEG/PPG-19/19 DIMETHICONE∙HYDROGENATED POLYISOBUTENE∙XANTHAN GUM∙ERYTHRITOL∙SODIUM ACETYLATED HYALURONATE∙ROSA ROXBURGHII FRUIT EXTRACT∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙PPG-17∙DISODIUM EDTA∙PEG-60 GLYCERYL ISOSTEARATE∙TRIETHANOLAMINE∙CARBOMER∙ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER∙SODIUM METAPHOSPHATE∙BHT∙TOCOPHEROL∙SODIUM METABISULFITE∙POLYMETHYLSILSESQUIOXANE∙ALCOHOL∙FRAGRANCE∙IRON OXIDES∙MICA∙TITANIUM DIOXIDE∙
- Other information
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- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE SHEER FLUID VEIL
avobenzone, octinoxate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 771 mg in 30 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2282 mg in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 617 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XYLITOL (UNII: VCQ006KQ1E) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) XANTHAN GUM (UNII: TTV12P4NEE) ERYTHRITOL (UNII: RA96B954X6) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) PPG-17 (UNII: OV0Q322E0U) EDETATE DISODIUM (UNII: 7FLD91C86K) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) TROLAMINE (UNII: 9O3K93S3TK) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM METABISULFITE (UNII: 4VON5FNS3C) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALCOHOL (UNII: 3K9958V90M) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-206-10 1 in 1 CARTON 09/01/2014 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2014 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-206) , analysis(58411-206)
