GOLDEN RAY SUNSCREEN (DEEP TINTED)- zinc oxide lotion 
A-Frame SunCo Inc

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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Golden Ray Sunscreen (Deep Tinted)

Golden Ray Sunscreen (Deep Tinted)

PDP

GOLDEN RAY SUNSCREEN (DEEP TINTED) 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82184-1350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE132 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82184-1350-21 in 1 CARTON03/08/2022
1NDC:82184-1350-128 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:82184-1350-360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/08/2022
Labeler - A-Frame SunCo Inc (118248026)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(82184-1350)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(82184-1350) , manufacture(82184-1350)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(82184-1350) , pack(82184-1350)

Revised: 3/2023
Document Id: f6543cc2-45f9-69d5-e053-2a95a90a4a93
Set id: d9b61959-9fd4-92cf-e053-2a95a90aa80a
Version: 3
Effective Time: 20230307
 
A-Frame SunCo Inc