OARS AND ALPS SPF 50 MINERAL- zinc oxide lotion

Oars and Alps SPF 50 Mineral by

Drug Labeling and Warnings

Oars and Alps SPF 50 Mineral 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

Zinc Oxide - 19.6%

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.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.

Reapply:

-At least every two hours
-After 80 minutes of swimming or sweating.
-Immediately after towel drying.
Children under six months: Ask a doctor.

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.​

INACTIVE INGREDIENT

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sclerocarya Birrea Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

QUESTIONS

Contact Hi@oarsandalps.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OARS AND ALPS SPF 50 MINERAL 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83046-371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEVOMENOL (UNII: 24WE03BX2T)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
TOCOPHEROL (UNII: R0ZB2556P8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCO GLUCOSIDE (UNII: ICS790225B)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83046-371-28	177 mL in 1 TUBE; 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)