Label: CLE DE PEAU BEAUTE LONG-LASTING HYDRATING VEIL- avobenzone, octinoxate, and octocrylene emulsion
- NDC Code(s): 58411-623-60
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 18, 2020
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- Official Label (Printer Friendly)
- 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 two 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▪GLYCERIN▪DIMETHICONE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪BARIUM SULFATE▪PEG/PPG-19/19 DIMETHICONE▪HYDROGENATED POLYISOBUTENE▪ERYTHRITOL▪XYLITOL▪TREHALOSE▪ARGANIA SPINOSA KERNEL OIL▪XANTHAN GUM▪POLYQUATERNIUM-51▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪TRIMETHYLSILOXYSILICATE▪ROSA ROXBURGHII FRUIT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER▪PERILLA OCYMOIDES LEAF EXTRACT▪PPG-17▪DISODIUM EDTA▪TRIETHANOLAMINE▪PEG-60 GLYCERYL ISOSTEARATE▪CARBOMER▪SILICA▪ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER▪SODIUM METAPHOSPHATE▪BHT▪TOCOPHEROL▪SODIUM CITRATE▪SODIUM METABISULFITE▪THEANINE▪CITRIC ACID▪POLYMETHYLSILSESQUIOXANE▪ALUMINUM HYDROXIDE▪TRIETHOXYCAPRYLYLSILANE▪METHYLPARABEN▪PHENOXYETHANOL▪FRAGRANCE▪IRON OXIDES▪TITANIUM DIOXIDE▪MICA▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE LONG-LASTING HYDRATING VEIL
avobenzone, octinoxate, and octocrylene emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-623 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.795 g in 30 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.38 g in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.635 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) BARIUM SULFATE (UNII: 25BB7EKE2E) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) XYLITOL (UNII: VCQ006KQ1E) ERYTHRITOL (UNII: RA96B954X6) PPG-17 (UNII: OV0Q322E0U) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TREHALOSE (UNII: B8WCK70T7I) ARGAN OIL (UNII: 4V59G5UW9X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM METABISULFITE (UNII: 4VON5FNS3C) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCINE (UNII: TE7660XO1C) THEANINE (UNII: 8021PR16QO) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) MICA (UNII: V8A1AW0880) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-623-60 1 in 1 CARTON 01/01/2021 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
