Label: SHISEIDO REVITALESSENCE SKIN GLOW PRIMER- avobenzone, octinoxate, and octocrylene emulsion
- NDC Code(s): 58411-894-60
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 13, 2025
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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･ALCOHOL DENAT.･GLYCERIN･BUTYLENE GLYCOL･NIACINAMIDE･SILICA･ISODECYL NEOPENTANOATE･TRIETHYLHEXANOIN･GLYCERYL DIISOSTEARATE･PEG-60 HYDROGENATED CASTOR OIL･LACTOBACILLUS/RICE FERMENT･XANTHAN GUM･TOCOPHERYL ACETATE･POLYQUATERNIUM-51･LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL･SANGUISORBA OFFICINALIS ROOT EXTRACT･SODIUM ACETYLATED HYALURONATE･CITRUS JUNOS SEED EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･BATYL ALCOHOL･BEHENYL ALCOHOL･CARBOMER･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･POTASSIUM HYDROXIDE･ALCOHOL･ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER･TOCOPHEROL･TRISODIUM EDTA･SODIUM METAPHOSPHATE･SODIUM METABISULFITE･BHT･CHLORPHENESIN･PHENOXYETHANOL･IRON OXIDES･
- Other information
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- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO REVITALESSENCE SKIN GLOW PRIMER
avobenzone, octinoxate, and octocrylene emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-894 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.77925 g in 30 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.52733 g in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5585 g in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) LAVENDER OIL (UNII: ZBP1YXW0H8) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CITRUS JUNOS SEED (UNII: UY43O1Q45N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BATILOL (UNII: 39YR661C4U) DOCOSANOL (UNII: 9G1OE216XY) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) ALCOHOL (UNII: 3K9958V90M) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EDETATE TRISODIUM (UNII: 420IP921MB) SODIUM METAPHOSPHATE (UNII: 532IUT7IRV) SODIUM METABISULFITE (UNII: 4VON5FNS3C) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-894-60 1 in 1 CARTON 01/01/2023 1 30 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 DRUG M020 01/01/2023 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Registrant - Shiseido America Inc. (782677132) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 ANALYSIS(58411-894) , MANUFACTURE(58411-894)
