Label: CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion
- NDC Code(s): 58411-454-10
- 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 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 ∙ DIPROPYLENE GLYCOL ∙ SD ALCOHOL 40-B ∙ GLYCERIN ∙ HYDROGENATED POLYDECENE ∙ XYLITOL・DIMETHICONE ∙ ISODODECANE ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ PEG-5 GLYCERYL STEARATE ∙ SILICA ∙ ISOSTEARIC ACID ∙ DIPHENYLSILOXY PHENYL TRIMETHICONE ∙ XANTHAN GUM ∙ TREHALOSE ∙ TOCOPHERYL ACETATE ∙ PEG/PPG ∙ 17/4 DIMETHYL ETHER ∙ PHYTOSTERYL MACADAMIATE ∙ GINKGO BILOBA LEAF EXTRACT ∙ ANGELICA ACUTILOBA ROOT EXTRACT ∙ PAEONIA ALBIFLORA ROOT EXTRACT ∙ CRATAEGUS MONOGYNA FLOWER EXTRACT ∙ PANAX GINSENG ROOT EXTRACT ∙ GLYCINE ∙ ONONIS SPINOSA ROOT EXTRACT ∙ HYDROLYZED SILK ∙ ROSA CANINA FRUIT EXTRACT ∙ ZANTHOXYLUM PIPERITUM PEEL EXTRACT ∙ HIBISCUS ESCULENTUS FRUIT EXTRACT ∙ FAGUS SYLVATICA BUD EXTRACT ∙ SODIUM ACETYLATED HYALURONATE ∙ PERILLA OCYMOIDES LEAF EXTRACT ∙ ROSA ROXBURGHII FRUIT EXTRACT ∙ HYDROLYZED CONCHIOLIN PROTEIN ∙ ISODONIS JAPONICUS LEAF/STALK EXTRACT ∙ BUPLEURUM FALCATUM ROOT EXTRACT ∙ PPG-17 ∙ TRIETHANOLAMINE ∙ GLYCERYL STEARATE SE ∙ BEHENYL ALCOHOL ∙ BEHENIC ACID ∙ STEARIC ACID ∙ BUTYLENE GLYCOL ∙ BATYL ALCOHOL ∙ THEANINE ∙ PEG-30 PHYTOSTEROL ∙ CARBOMER ∙ DISODIUM EDTA・ALCOHOL ∙ CELLULOSE GUM ∙ SODIUM METAPHOSPHATE ∙ BHT ∙ TOCOPHEROL ∙ METHYLPARABEN ∙ ETHYLPARABEN ∙ PHENOXYETHANOL ∙ BENZOIC ACID ∙ FRAGRANCE ∙ TITANIUM DIOXIDE ∙ MICA ∙ IRON OXIDES ∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 125 mL Container Carton
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N
avobenzone, octinoxate, octocrylene, and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-454 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3200 mg in 125 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 9472 mg in 125 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2560 mg in 125 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1280 mg in 125 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) XYLITOL (UNII: VCQ006KQ1E) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOSTEARIC ACID (UNII: X33R8U0062) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) XANTHAN GUM (UNII: TTV12P4NEE) TREHALOSE (UNII: B8WCK70T7I) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) GINKGO (UNII: 19FUJ2C58T) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J) ASIAN GINSENG (UNII: CUQ3A77YXI) GLYCINE (UNII: TE7660XO1C) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) PPG-17 (UNII: OV0Q322E0U) TROLAMINE (UNII: 9O3K93S3TK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) BEHENIC ACID (UNII: H390488X0A) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BATILOL (UNII: 39YR661C4U) THEANINE (UNII: 8021PR16QO) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) ALCOHOL (UNII: 3K9958V90M) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-454-10 1 in 1 CARTON 02/01/2019 1 125 mL in 1 CONTAINER; 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 02/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 ANALYSIS(58411-454) , MANUFACTURE(58411-454)
