Label: SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER- avobenzone, octinoxate, octocrylene, and oxybenzone cream
- NDC Code(s): 58411-255-60
- 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 19, 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•GLYCERIN•DIPROPYLENE GLYCOL•CAPRYLIC/CAPRIC TRIGLYCERIDE•BEHENYL ALCOHOL•BUTYLENE GLYCOL•ISOHEXADECANE•SD ALCOHOL 40-B•SORBITOL•SILICA•MYRISTYL MYRISTATE•DIMETHICONE•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•STEARYL ALCOHOL•TRIISOSTEARIN•PHYTOSTERYL MACADAMIATE•TOCOPHERYL ACETATE•2-O-ETHYL ASCORBIC ACID•POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE•ARGININE HCl•SAXIFRAGA SARMENTOSA EXTRACT•SAPINDUS MUKUROSSI PEEL EXTRACT•PANAX GINSENG ROOT EXTRACT•ANGELICA ACUTILOBA ROOT EXTRACT•SODIUM ACETYLATED HYALURONATE•HYDROXYPROLINE•UNCARIA GAMBIR EXTRACT•CHLORELLA VULGARIS EXTRACT•THYMUS SERPILLUM EXTRACT•BEHENETH-20•ALCOHOL•SUCCINOGLYCAN•TRISODIUM EDTA•SODIUM CITRATE•SODIUM METAPHOSPHATE•CITRIC ACID•BHT•SODIUM METABISULFITE•TOCOPHEROL•PHENOXYETHANOL•FRAGRANCE•IRON OXIDES•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-255 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1922 mg in 75 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3767 mg in 75 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3844 mg in 75 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1153 mg in 75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) DOCOSANOL (UNII: 9G1OE216XY) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOHEXADECANE (UNII: 918X1OUF1E) SORBITOL (UNII: 506T60A25R) DIMETHICONE (UNII: 92RU3N3Y1O) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TRIISOSTEARIN (UNII: 71503RH8KG) BEHENETH-20 (UNII: BJ4GP2IFLN) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALCOHOL (UNII: 3K9958V90M) EDETATE TRISODIUM (UNII: 420IP921MB) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) ASIAN GINSENG (UNII: CUQ3A77YXI) HYDROXYPROLINE (UNII: RMB44WO89X) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CHLORELLA VULGARIS (UNII: RYQ4R60M02) THYMUS SERPYLLUM (UNII: 86H4S6K51N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-255-60 1 in 1 CARTON 09/01/2015 1 75 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 not final part352 09/01/2015 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-255) , analysis(58411-255)
