Label: SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY- avobenzone, octinoxate, octocrylene, and homosalate cream
- NDC Code(s): 58411-479-50
- 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 October 17, 2019
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
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: ask a doctor
-
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
-
Inactive Ingredients
WATER▪DIPROPYLENE GLYCOL▪GLYCERIN▪DIMETHICONE▪SD ALCOHOL 40-B▪BEHENYL ALCOHOL▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪HYDROGENATED POLYDECENE▪;BEHENETH-20▪SILICA▪ISOHEXADECANE▪STEARYL ALCOHOL▪C30-45 ALKYL METHICONE▪POTASSIUM METHOXYSALICYLATE▪XANTHAN GUM▪ERYTHRITOL▪TOCOPHERYL ACETATE▪PEG/PPG-14/7 DIMETHYL ETHER▪PEG/PPG-17/4 DIMETHYL ETHER▪ROSA DAMASCENA FLOWER WATER▪PHYTOSTERYL MACADAMIATE▪CAFFEINE▪LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL▪ANGELICA KEISKEI LEAF/STEM EXTRACT▪OLEA EUROPAEA (OLIVE) LEAF EXTRACT▪LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT▪INOSITOL▪CAMELLIA SINENSIS LEAF EXTRACT▪CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT▪ZIZIPHUS JUJUBA FRUIT EXTRACT▪ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT▪HYDROLYZED SILK▪POLYQUATERNIUM-51▪BUPLEURUM FALCATUM ROOT EXTRACT▪PPG-17▪C30-45 OLEFIN▪BEHENETH-30▪BUTYLENE GLYCOL▪POLYVINYL ALCOHOL▪CELLULOSE GUM▪BHT▪SODIUM METAPHOSPHATE▪TRISODIUM EDTA▪ALCOHOL▪TOCOPHEROL▪PPG-3 DIPIVALATE▪SODIUM METABISULFITE▪CELLULOSE▪PHENOXYETHANOL▪FRAGRANCE▪IRON OXIDES▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
-
INGREDIENTS AND APPEARANCE
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY
avobenzone, octinoxate, octocrylene, and homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-479 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.278 g in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.785 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.534 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.557 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) DOCOSANOL (UNII: 9G1OE216XY) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) BEHENETH-20 (UNII: BJ4GP2IFLN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOHEXADECANE (UNII: 918X1OUF1E) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) C30-45 ALKYL METHICONE (UNII: NFX970DSI2) POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F) XANTHAN GUM (UNII: TTV12P4NEE) ERYTHRITOL (UNII: RA96B954X6) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K) ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) CAFFEINE (UNII: 3G6A5W338E) LAVENDER OIL (UNII: ZBP1YXW0H8) ANGELICA KEISKEI TOP (UNII: AP628M4TQO) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) LAMIUM ALBUM FLOWERING TOP (UNII: T95771X2XI) INOSITOL (UNII: 4L6452S749) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SAFFLOWER (UNII: 4VBL71TY4Y) JUJUBE FRUIT (UNII: G55HNL2C70) ROSEMARY (UNII: IJ67X351P9) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) PPG-17 (UNII: OV0Q322E0U) C30-45 OLEFIN (UNII: 6DWD51M0O8) BEHENETH-30 (UNII: 21Z34J9KN8) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM METABISULFITE (UNII: 4VON5FNS3C) .ALPHA.-CELLULOSE (UNII: I355QGZ19A) 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:58411-479-50 1 in 1 CARTON 01/01/2020 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 01/01/2020 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICAS INC. 782677132 MANUFACTURE(58411-479) , ANALYSIS(58411-479)
