OARS AND ALPS SPF 50 MINERAL- zinc oxide lotion 
Oars and Alps LLC

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.

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Oars & Alps - SPF 50 Mineral Lotion

Zinc Oxide - 19.6%

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.

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. If swallowed, get medical help or contact a Poison Control Center right away.

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.​

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

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

Contact Hi@oarsandalps.com

1

OARS AND ALPS SPF 50 MINERAL 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83046-371
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83046-371-28177 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02012/01/2022
Labeler - Oars and Alps LLC (040241941)

Revised: 1/2023
Document Id: f395bc39-daa6-53b8-e053-2995a90a5f48
Set id: f395bc39-daa5-53b8-e053-2995a90a5f48
Version: 1
Effective Time: 20230131
 
Oars and Alps LLC