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
- 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 October 29, 2018
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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 (550 MW) (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) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) ALCOHOL (UNII: 3K9958V90M) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (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 final part352 02/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-454) , ANALYSIS(58411-454)
