Label: PROJECT REEF MINERAL SUNSCREEN SPF-30- zinc oxide lotion
- NDC Code(s): 81637-289-00
- Packager: Project Reef LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
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Directions:
• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.
Sun Protection Measures. - Other Information:
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Inactive Ingredients:
Algae Extract, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, *Butyrospermum Parkii (Shea) Butter, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, *Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Ethyl Vanillin, Fucus Vesiculosus (Seaweed) Extract, *Glycerin, Glyceryl Stearate, Helianthus Annuus, *Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Raspberry) Extract, Stearic Acid, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol. *Denotes Organic Ingredient
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INGREDIENTS AND APPEARANCE
PROJECT REEF MINERAL SUNSCREEN SPF-30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81637-289 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 140 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) SHEA BUTTER (UNII: K49155WL9Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) COCONUT OIL (UNII: Q9L0O73W7L) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DEHYDROACETIC ACID (UNII: 2KAG279R6R) ETHYL VANILLIN (UNII: YC9ST449YJ) FUCUS VESICULOSUS (UNII: 535G2ABX9M) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) LAVENDER OIL (UNII: ZBP1YXW0H8) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) RASPBERRY (UNII: 4N14V5R27W) STEARIC ACID (UNII: 4ELV7Z65AP) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81637-289-00 946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/21/2022 Labeler - Project Reef LLC (096500461)
