ACTIVATED MINERAL SUNSCREEN- activated mineral sunscreen cream 
Reve Skincare LLC

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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Active Ingredients

Zinc Oxide 14.2%

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

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 docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 15 minutes before sun exposure
• reapply: •at least every 2 hours.

• use a water resistant sunscreen if swimming or sweating
• 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
value 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Niacinamide, Butyloctyl Salicylate, Propanediol, Squalene, Aloe Barbadensis Leaf Juice, 1,2-Hexanediol, Sodium Acrylate/Sodium Acyloyldimethyl Tauarate Copolymer, Cetyl Alcohol, Glycol Stearate, Hydroxyacetophenone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Vaccinium Vitis-Idaea Fruit Extract, Isohexadecane, Xanthan Gum, Polysorbate 80, Sorbitan Oleate, Phenoxyethanol, Jojoba Esters, Citric Acid, Gluconolactone, Plankotn Extract, Alumina, Sodium Benzoate, Potassium Sorbate, Silica, Calcium Glucate. May Contain (+/-): Titanium Dioxide (CI77891), Iron Oxides (CI 774941, 77492, 77499)

Other Information

• protect the product in this container from excessive
heat and direct sun

Questions or Comments?

Call our Sunshine Concierge: 855-744-6366 (855-Shine-On)

Principal Display Panel

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ACTIVATED MINERAL SUNSCREEN 
activated mineral sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83083-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE142.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PROPANEDIOL (UNII: 5965N8W85T)  
SQUALANE (UNII: GW89575KF9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
VACCINIUM VITIS-IDAEA FRUIT OIL (UNII: 16Y54799WZ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
JOJOBA OIL (UNII: 724GKU717M)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
ALUMINUM (UNII: CPD4NFA903)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SILICON (UNII: Z4152N8IUI)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83083-001-501 in 1 CARTON06/01/2023
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 finalpart35206/01/2023
Labeler - Reve Skincare LLC (118831764)

Revised: 6/2023
 
Reve Skincare LLC