Label: SHISEIDO BENEFIANCE NUTRIPERFECT DAY- avobenzone, octinoxate, and octocrylene cream
- NDC Code(s): 58411-351-50, 58411-351-51, 58411-351-52
- 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 27, 2019
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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, DIPROPYLENE GLYCOL, DIMETHICONE, GLYCERYL STEARATE SE, BEHENYL ALCOHOL, PEG/PPG-14/7 DIMETHYL ETHER, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, HYDROGENATED POLYDECENE, ISOPROPYL MYRISTATE, MYRISTYL MYRISTATE, MICROCRYSTALLINE WAX, PEG-40 STEARATE, SILICA, CARNOSINE, XANTHAN GUM, ERYTHRITOL, TOCOPHERYL ACETATE, POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE, PANTHENYL ETHYL ETHER, SODIUM ACETYLATED HYALURONATE, SORBITAN TRISTEARATE, STEARYL ALCOHOL, CELLULOSE GUM, SODIUM METAPHOSPHATE, TRISODIUM EDTA, BHT, SODIUM METABISULFITE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES,
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO BENEFIANCE NUTRIPERFECT DAY
avobenzone, octinoxate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-351 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1286 mg in 51.45 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3807 mg in 51.45 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1029 mg in 51.45 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PEG-40 STEARATE (UNII: ECU18C66Q7) CARNOSINE (UNII: 8HO6PVN24W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN TRISTEARATE (UNII: 6LUM696811) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ERYTHRITOL (UNII: RA96B954X6) EDETATE TRISODIUM (UNII: 420IP921MB) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PANTHENYL ETHYL ETHER (UNII: F4WMF8NX3B) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-351-50 1 in 1 CARTON 11/01/2012 1 51.45 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:58411-351-51 1 in 1 CARTON 11/01/2012 2 4.12 g in 1 JAR; Type 0: Not a Combination Product 3 NDC:58411-351-52 1 in 1 CARTON 11/01/2012 3 10.29 g in 1 JAR; 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 11/01/2012 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-351) , ANALYSIS(58411-351)
