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
Drug Label Information
Updated December 18, 2024
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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 POLYISOBUTENE (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 DRUG M020 01/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 ANALYSIS(58411-623) , MANUFACTURE(58411-623)
