SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N- avobenzone, octinoxate, octocrylene, and oxybenzone cream 
SHISEIDO AMERICAS CORPORATION

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.

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SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5% Sunscreen
OCTINOXATE 7.4% Sunscreen
OCTOCRYLENE 3.0% Sunscreen
OXYBENZONE 1.0% Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SHI SEIDO

WHITE LUCENT

All Day Brightener

BROAD SPECTRUM
SPF 23

SUNSCREEN

PROAPPROACH×2

50mL NET WT. 1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N 
avobenzone, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-295
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1283 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3796 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1539 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE513 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-295-601 in 1 CARTON02/01/2017
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2017
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-295) , analysis(58411-295)

Revised: 12/2018
Document Id: 7cf27f1b-c08e-7e5f-e053-2991aa0a0ac0
Set id: e2306668-c4db-4077-b959-361a2712ace0
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION