Oars & Alps SPF 30 100% Mineral Sunscreen Lotion

Oars and Alps SPF 30 100% Mineral Sunscreen by

Drug Labeling and Warnings

Oars and Alps SPF 30 100% Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Oars and Alps LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OARS AND ALPS SPF 30 100% MINERAL SUNSCREEN- 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 30 100% Mineral Sunscreen Lotion

Zinc Oxide - 17.6%

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.

Directions

Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

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.​

Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Hydrolyzed Wheat Protein/PVP Crosspolymer, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Styrene/Acrylates Copolymer, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water

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

Contact Hi@oarsandalps.com

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OARS AND ALPS SPF 30 100% MINERAL SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83046-363
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LEVOMENOL (UNII: 24WE03BX2T)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
COCONUT OIL (UNII: Q9L0O73W7L)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
DOCOSANOL (UNII: 9G1OE216XY)  
SHEA BUTTER (UNII: K49155WL9Y)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
WATER (UNII: 059QF0KO0R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
COCO GLUCOSIDE (UNII: ICS790225B)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOA BUTTER (UNII: 512OYT1CRR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83046-363-28177 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/2022
Labeler - Oars and Alps LLC (040241941)

Revised: 11/2022
 

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