Label: SHISEIDO WHITE LUCENT DAY- avobenzone, octinoxate, and octocrylene emulsion
- NDC Code(s): 58411-463-10
- 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 15, 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
- children under 6 months: ask a doctor
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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
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Inactive Ingredients
Water, SD Alcohol 40-B, Dimethicone, Dipropylene Glycol, Glycerin, Diisopropyl Sbeacate, Peg-60 Hydrogenated Castor Oil, Potassium Methoxysalicylate, Erythritol, Xanthan Gum, Tocopheryl Acetate, Peg/PPG-14/7 Dimethyl Ether, Peg/PPG-17/4 Dimethyl Ether, Dipotassium Glycyrrhizate, 2-O-Ethyl Ascorbic Acid, Caffeine, Ascorbyl Tetraisopalmitate, Phytosteryl Macadamiate, Angelica Keiskei Leaf/Stem Extract, Paeonia Albiflora Root Extract, Cratagus Monogyna Flower Extract, Rehmannia Chinesis Root Extract, Ziziphu Jujuba Fruit Extract, Polyquaternium 51, PPG-17, Peg-240/HDI Copolymer BIS-Decyltetradeceth-20 Ether, Triethanolamine, Silica, Butylene Glycol, Isostearic Acid, PPG-3 Dipivalate, HDI/Trimethylol Hexyllactone Crosspolymer, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT, Sodium Metaphosphate, Alcohol, Tocopherol, Disodium EDTA, Sodium Metabisulfite, Prunus Yedoensis Leaf Extract, Phenoxyethanol, Benzoic Acid, Fragrance, Titanium Dioxide, Mica, Iron Oxides
- Other information
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- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO WHITE LUCENT DAY
avobenzone, octinoxate, and octocrylene emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-463 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.285 g in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.8036 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F) 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) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) CAFFEINE (UNII: 3G6A5W338E) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ANGELICA KEISKEI TOP (UNII: AP628M4TQO) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J) REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) JUJUBE FRUIT (UNII: G55HNL2C70) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) PPG-17 (UNII: OV0Q322E0U) TROLAMINE (UNII: 9O3K93S3TK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOSTEARIC ACID (UNII: X33R8U0062) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) 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:58411-463-10 1 in 1 CARTON 01/01/2019 1 50 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 FINAL part352 01/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICAS INC. 782677132 MANUFACTURE(58411-463) , ANALYSIS(58411-463)
