Label: SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY- avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone cream
- NDC Code(s): 58411-439-50
- 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 May 9, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
-
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
-
Inactive Ingredients
WATER•GLYCERIN•DIPROPYLENE GLYCOL•BUTYLENE GLYCOL•BEHENYL ALCOHOL•SD ALCOHOL 40-B•SILICA•DIMETHICONE•ISODODECANE•ISOHEXADECANE•SORBITOL•BEHENETH-20•MYRISTYL MYRISTATE•PHYTOSTERYL MACADAMIATE•ERYTHRITOL•XANTHAN GUM•TOCOPHERYL ACETATE•PEG/PPG-14/7 DIMETHYL ETHER•PEG/PPG-17/4 DIMETHYL ETHER•CAFFEINE•SAPINDUS MUKOROSSI PEEL EXTRACT•ANGELICA KEISKEI LEAF/STEM EXTRACT•CAMELLIA SINENSIS LEAF EXTRACT•CITRUS JUNOS SEED EXTRACT•ZIZIPHUS JUJUBA FRUIT EXTRACT•EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT•CURCUMA LONGA (TURMERIC) RHIZOME EXTRACT•POLYQUATERNIUM-51•SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT•CHLORELLA VULGARIS EXTRACT•PPG-17•STEARYL ALCOHOL•BEHENETH-30•ALCOHOL•CARBOMER•CELLULOSE GUM•TRISODIUM EDTA•HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•SODIUM CITRATE•BHT•SODIUM METAPHOSPHATE•POTASSIUM HYDROXIDE•CITRIC ACID•TOCOPHEROL•PPG-3 DIPIVALATE•SODIUM METABISULFITE•PHENOXYETHANOL•FRAGRANCE•IRON OXIDES•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
-
INGREDIENTS AND APPEARANCE
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY
avobenzone, homosalate, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-439 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1032 mg in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2580 mg in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3818 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1548 mg in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 774 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DOCOSANOL (UNII: 9G1OE216XY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) ISOHEXADECANE (UNII: 918X1OUF1E) SORBITOL (UNII: 506T60A25R) BEHENETH-20 (UNII: BJ4GP2IFLN) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) ERYTHRITOL (UNII: RA96B954X6) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K) CAFFEINE (UNII: 3G6A5W338E) SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U) ANGELICA KEISKEI TOP (UNII: AP628M4TQO) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CITRUS JUNOS SEED (UNII: UY43O1Q45N) JUJUBE FRUIT (UNII: G55HNL2C70) TURMERIC (UNII: 856YO1Z64F) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) CHLORELLA VULGARIS (UNII: RYQ4R60M02) PPG-17 (UNII: OV0Q322E0U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BEHENETH-30 (UNII: 21Z34J9KN8) ALCOHOL (UNII: 3K9958V90M) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) EDETATE TRISODIUM (UNII: 420IP921MB) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-439-50 1 in 1 CARTON 06/01/2018 1 50 mL 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 final part352 06/01/2018 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-439) , ANALYSIS(58411-439)
