ACTIVATED MINERAL SUNSCREEN TINTED cream

Activated Mineral Sunscreen Tinted by

Drug Labeling and Warnings

Activated Mineral Sunscreen Tinted by is a Otc medication manufactured, distributed, or labeled by Reve Skincare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, Sodium Acrylate/Sodium Acyloyldimethyl Tauarate Copolymer, 1,2-Hexanediol, Cetyl Alcohol, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Polyisobutene, Glycerin, Glyceryl Stearate, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Vaccinium Vitis-Idaea Fruit Extract, Xanthan Gum, Caprylyl/Capryl Glucoside, 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)

Purpose

Sunscreen

Keep out of reach of children.

Keep out of reach of children.

Topical

Topical

Principal Display Panel

INGREDIENTS AND APPEARANCE

ACTIVATED MINERAL SUNSCREEN TINTED 
activated mineral sunscreen tinted cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83083-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	142.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83083-002-50	1 in 1 CARTON	03/25/2025
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 Drug	M020	03/25/2025

Labeler - Reve Skincare LLC (118831764)