OARS AND ALPS SPF 50 100% MINERAL ANTIOXIDANT SUNSCREEN- titanium dioxide, zinc oxide spray

Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen by

Drug Labeling and Warnings

Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen by is a Otc medication manufactured, distributed, or labeled by Oars and Alps LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide - 3.4%

Zinc Oxide - 15.7%

PURPOSE

Sunscreen

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 doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

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

• Protect the product in this container from excessive heat and direct sun
• Avoid spraying on facbrics - may cause discoloration

QUESTIONS

Contact Hi@oarsandalps.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OARS AND ALPS SPF 50 100% MINERAL ANTIOXIDANT SUNSCREEN 
titanium dioxide, zinc oxide spray

Product 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)