Label: SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N- avobenzone, octinoxate, octocrylene, and oxybenzone cream
- NDC Code(s): 58411-295-60
- 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 13, 2018
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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
- 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•SD ALCOHOL 40-B•DIMETHICONE•DIPROPYLENE GLYCOL•DIISOPROPYL SEBACATE•GLYCERIN•PEG-60 HYDROGENATED CASTOR OIL•POTASSIUM METHOXYSALICYLATE•XANTHAN GUM•PEG/PPG-14/7 DIMETHYL ETHER•TOCOPHERYL ACETATE•2-O-ETHYL ASCORBIC ACID•ASCORBYL TETRAISOPALMITATE•SODIUM HYALURONATE•PAEONIA SUFFRUTICOSA ROOT EXTRACT•CRATAEGUS MONOGYNA FLOWER EXTRACT•POLYQUATERNIUM-51•REHMANNIA CHINENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•HOUTTUYNIA CORDATA EXTRACT•PPG-17•PEG-240/HDI COPOLYMER BIS-DECYLTETRADECETH-20 ETHER•TRIETHANOLAMINE•SILICA•ISOSTEARIC ACID•BUTYLENE GLYCOL•CARBOMER•ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER•ALCOHOL•BHT•SODIUM METAPHOSPHATE•DISODIUM EDTA•TOCOPHEROL•ZINC OXIDE•SODIUM METABISULFITE•ALUMINA•PRUNUS YEDOENSIS LEAF EXTRACT•METHYLPARABEN•ETHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•MICA•IRON OXIDES•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-295 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1283 mg in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3796 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1539 mg in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 513 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) GLYCERIN (UNII: PDC6A3C0OX) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F) XANTHAN GUM (UNII: TTV12P4NEE) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22) PPG-17 (UNII: OV0Q322E0U) TROLAMINE (UNII: 9O3K93S3TK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOSTEARIC ACID (UNII: X33R8U0062) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ZINC OXIDE (UNII: SOI2LOH54Z) SODIUM METABISULFITE (UNII: 4VON5FNS3C) ALUMINUM OXIDE (UNII: LMI26O6933) PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-295-60 1 in 1 CARTON 02/01/2017 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 not final part352 02/01/2017 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-295) , analysis(58411-295)
