Label: OARS AND ALPS SPF 50 100% MINERAL ANTIOXIDANT SUNSCREEN- titanium dioxide, zinc oxide spray
- NDC Code(s): 83046-369-13
- Packager: Oars and Alps LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 31, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- Apply generously and evenly 15 minutes before sun exposure
- Hold container 4-6 inches from the skin to apply
- Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale.
- Do not apply in windy conditions.
- Use in well ventilated area.
- Reapply: After 80 minutes of swimming or sweating, immedately after towl drying, at least every 2 hours.
- 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 six months: Ask a doctor.
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sclerocarya Birrea Seed Oil, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OARS AND ALPS SPF 50 100% MINERAL ANTIOXIDANT SUNSCREEN
titanium dioxide, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83046-369 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.7 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.4 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) BENTONITE (UNII: A3N5ZCN45C) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) WATER (UNII: 059QF0KO0R) C18-C21 ALKANE (UNII: 33822S0M40) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ) TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCO GLUCOSIDE (UNII: ICS790225B) PROPANEDIOL (UNII: 5965N8W85T) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) LEVOMENOL (UNII: 24WE03BX2T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) SODIUM GLUCONATE (UNII: R6Q3791S76) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83046-369-13 177 mL in 1 CAN; Type 0: Not a Combination Product 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/01/2022 Labeler - Oars and Alps LLC (040241941)