Label: CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER N- avobenzone, octinoxate, and octocrylene cream
- NDC Code(s): 58411-237-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 26, 2018
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- Official Label (Printer Friendly)
- Drug Facts
- 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
- Other information
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Inactive Ingredients
WATER∙XYLITOL∙DIPROPYLENE GLYCOL∙GLYCERIN∙SD ALCOHOL 40-B∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙ISODODECANE∙SILICA∙TRIETHYLHEXANOIN∙HYDROGENATED POLYDECENE∙PPG-17∙DIMETHICONE∙METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HCl∙XANTHAN GUM∙TOCOPHERYL ACETATE∙PEG/PPG-14/7 DIMETHYL ETHER∙PHYTOSTERYL MACADAMIATE∙GLYCYL GLYCINE∙SODIUM ACETYLATED HYALURONATE∙SODIUM HYALURONATE∙LAURYL BETAINE∙NUPHAR JAPONICUM ROOT EXTRACT∙BUPLEURUM FALCATUM ROOT EXTRACT∙GINKGO BILOBA LEAF EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙BEHENETH-20∙BEHENYL ALCOHOL∙HYDROGENATED PALM OIL∙ELAEIS GUINEENSIS (PALM) KERNEL OIL∙STEARYL ALCOHOL∙ELAEIS GUINEENSIS (PALM) OIL∙BUTYLENE GLYCOL∙ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER∙CARBOMER∙PEG-10 DIMETHICONE∙POTASSIUM HYDROXIDE∙CELLULOSE GUM∙SODIUM METAPHOSPHATE∙ALCOHOL∙DISODIUM EDTA∙BHT∙ISOSTEARIC ACID∙CINNAMOMUM CASSIA BARK EXTRACT∙TOCOPHEROL∙CITRIC ACID∙PHENOXYETHANOL∙SODIUM BENZOATE∙FRAGRANCE∙IRON OXIDES∙
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- PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER N
avobenzone, octinoxate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 518 mg in 20 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1532 mg in 20 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 414 mg in 20 mL Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PALM OIL (UNII: 5QUO05548Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ALCOHOL (UNII: 3K9958V90M) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOSTEARIC ACID (UNII: X33R8U0062) CHINESE CINNAMON (UNII: WS4CQ062KM) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) ISODODECANE (UNII: A8289P68Y2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) PPG-17 (UNII: OV0Q322E0U) DIMETHICONE (UNII: 92RU3N3Y1O) METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HYDROCHLORIDE (UNII: ZV6O50F5CP) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) DIGLYCINE (UNII: 10525P22U0) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LAURYL BETAINE (UNII: Y4P927Q133) NUPHAR JAPONICA ROOT (UNII: 3OPM78C6RQ) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) GINKGO (UNII: 19FUJ2C58T) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BEHENETH-20 (UNII: BJ4GP2IFLN) DOCOSANOL (UNII: 9G1OE216XY) HYDROGENATED PALM OIL (UNII: 257THB963H) PALM KERNEL OIL (UNII: B0S90M0233) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-237-10 1 in 1 CARTON 10/01/2014 1 20 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2014 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-237) , analysis(58411-237)
