Oars & Alps SPF 35 Everyday Sunscreen Lotion

Oars and Alps SPF 35 Everyday Sunscreen by

Drug Labeling and Warnings

Oars and Alps SPF 35 Everyday 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 35 EVERYDAY SUNSCREEN- avobenzone, octisalate, octocrylene 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 35 Everyday Sunscreen Lotion

Avobenzone – 2.9%
Octisalate – 4.9%
Octocrylene – 7.5%

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 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.​

Aloe Barbadensis Leaf Juice, Astrocaryum Tucuma Seed Butter, Butyloctyl Salicylate, C18-21 Alkane, Cetearyl Phosphate. Cetyl Alcohol, Cetyl Hydroxyethylcellulose, Citric Acid, Cladonia Stellaris Extract, Ethyl Ferulate, Ethylhexyl Olivate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Methylheptylglycerin, Phenoxyethanol, Polyester-8, Propanediol, Sodium Gluconate, Sodium Hydroxide, Squalane, Tocopherol, VP/Hexadecene Copolymer, Water, Xanthan Gum

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

Contact Hi@oarsandalps.com

OARS AND ALPS SPF 35 EVERYDAY SUNSCREEN 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83046-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SQUALANE (UNII: GW89575KF9)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
CETEARYL PHOSPHATE (UNII: 4O6GCK4CTJ)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
ETHYL FERULATE (UNII: 5B8915UELW)
C18-C21 ALKANE (UNII: 33822S0M40)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL OLEATE (UNII: R34927QY59)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83046-362-28	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2022
2	NDC: 83046-362-80	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2022
3	NDC: 83046-362-47	3785 mL in 1 BOTTLE, PLASTIC; 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	01/01/2022

Labeler - Oars and Alps LLC (040241941)

Revised: 12/2022

Document Id: eec87c70-b33d-405c-e053-2995a90a1050

34390-5

Set id: ec6f0d8d-1e19-be71-e053-2a95a90a34ee

Version: 2

Effective Time: 20221201