RADIANCESHIELD GOLDEN TINT- radianceshield golden tint lotion 
The Skin Atelier, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredients: Zinc Oxide (10.5%), Titanium Dioxde (4.4%)

Apply in the morning, as the last product in your regiment or as needed, at least every 2 hours if in direct sunlight. 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 Broad Spectrum SPF Value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10 a.m. to 2 p.m., wear long sleeved shirts, pants, hats and sunglasses, children under 6 months of age: ask a doctor.

Apply in the morning, as the last product in your regiment or as needed, at least every 2 hours if in direct sunlight. 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 Broad Spectrum SPF Value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10 a.m. to 2 p.m., wear long sleeved shirts, pants, hats and sunglasses, children under 6 months of age: ask a doctor.

For external use only. Do not use on damaged or broken. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out if reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

For external use only. Do not use on damaged or broken. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out if reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Water, Butyloctyl Salicylate, Fatty Alcohol, Ethoxylated Sorbitan Ester, Sodium Hyaluronate, TRIETHOXYCAPRYLYLSILANE, Polysorbate 60, Heptyl Undecylenate, 4-t-Butylcyclohexanol, Dimethicone, Ethylhexyl Methoxycrylene, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Sodium Benzoate, BENZYL ALCOHOL, BENZOIC ACID, SORBIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, pOLYHYDROXYSTEARIC ACID, ALUMINA, STEARIC ACID, Butylene Glycol, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Ubiquinone, Tocopheryl Acetate, C12-15 Alkyl Benzoate, Phenoxyethanol, Disodium EDTA, NIACINAMIDE, Bisabolol, Hydroxymethoxyphenyl Decanone, Butylated hydroxytoluene, sODIUM ascorbyl phosphate, linalool, iron oxides

Helps prevent suburn if used as directed with other sun protection measures (see DIRECTIONS). Decreases risk of skin cancaer and early skin aging caused by the sun.

Helps prevent suburn if used as directed with other sun protection measures (see DIRECTIONS). Decreases risk of skin cancaer and early skin aging caused by the sun.

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RADIANCESHIELD GOLDEN TINT 
radianceshield golden tint lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71393-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
2,3-DICHLOROBENZOIC ACID (UNII: CGP39QV5WF)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
4-HYDROXYBENZYL ALCOHOL (UNII: 1A3AH1FP1B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
WATER (UNII: 059QF0KO0R)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
UBIDECARENONE (UNII: EJ27X76M46)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBIC ACID (UNII: X045WJ989B)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAESALPINIA SPINOSA WHOLE (UNII: O759MFY23D)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
4-TERT-BUTYLCYCLOHEXANOL, CIS- (UNII: L5067JRJ73)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71393-017-34115 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/31/201810/11/2019
Labeler - The Skin Atelier, Inc. (135049810)
Establishment
NameAddressID/FEIBusiness Operations
The Skin Atelier, Inc135049810manufacture(71393-017)

Revised: 1/2020
 
The Skin Atelier, Inc.