Label: CLE DE PEAU BEAUTE UV PROTECTIVE N- avobenzone, homosalate, octisalate, and octocrylene cream
- NDC Code(s): 58411-855-60
- 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 January 30, 2023
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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 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▪BUTYLENE GLYCOL▪GLYCERIN▪SILICA▪GLYCERYL DIISOSTEARATE▪ALCOHOL DENAT.▪CAPRYLYL METHICONE▪BEHENYL ALCOHOL▪C30-45 ALKYL METHICONE▪DIPROPYLENE GLYCOL▪DIMETHICONE▪AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER▪XANTHAN GUM▪TREHALOSE▪TOCOPHERYL ACETATE▪2-O-ETHYL ASCORBIC ACID▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪THYMUS SERPYLLUM EXTRACT▪GARCINIA MANGOSTANA BARK EXTRACT▪PANAX GINSENG ROOT EXTRACT▪FAGUS SYLVATICA BUD EXTRACT▪AMINOETHANESULFINIC ACID▪BUPLEURUM FALCATUM ROOT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪PERILLA OCYMOIDES LEAF EXTRACT▪POLYQUATERNIUM-51▪CRATAEGUS MONOGYNA FLOWER EXTRACT▪SAXIFRAGA SARMENTOSA EXTRACT▪GINKGO BILOBA LEAF EXTRACT▪MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT▪BEHENETH-20▪C30-45 OLEFIN▪STEARYL ALCOHOL▪DISODIUM EDTA▪CARBOMER▪POTASSIUM HYDROXIDE▪TOCOPHEROL▪SODIUM METAPHOSPHATE▪BHT▪ALCOHOL▪SODIUM METABISULFITE▪THEANINE▪SYZYGIUM JAMBOS LEAF EXTRACT▪PHENOXYETHANOL▪FRAGRANCE▪IRON OXIDES▪TITANIUM DIOXIDE▪MICA▪
- Other information
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- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE UV PROTECTIVE N
avobenzone, homosalate, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-855 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.2167 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.29 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.645 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.645 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) ALCOHOL (UNII: 3K9958V90M) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DOCOSANOL (UNII: 9G1OE216XY) C30-45 ALKYL METHICONE (UNII: NFX970DSI2) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) XANTHAN GUM (UNII: TTV12P4NEE) TREHALOSE (UNII: B8WCK70T7I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) ASIAN GINSENG (UNII: CUQ3A77YXI) FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W) HYPOTAURINE (UNII: 5L08GE4332) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM) CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) GINKGO (UNII: 19FUJ2C58T) MENTHA PIPERITA LEAF (UNII: A389O33LX6) BEHENETH-20 (UNII: BJ4GP2IFLN) C30-45 OLEFIN (UNII: 6DWD51M0O8) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM METAPHOSPHATE (UNII: 532IUT7IRV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) THEANINE (UNII: 8021PR16QO) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-855-60 1 in 1 CARTON 08/01/2022 1 50 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 08/01/2022 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
