OARS AND ALPS SPF 70 HYDRATING ANTIOXIDANT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Oars and Alps SPF 70 Hydrating Antioxidant Sunscreen by

Drug Labeling and Warnings

Oars and Alps SPF 70 Hydrating 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

Avobenzone - 2.9%
Homosalate - 9.8%
Octisalate - 4.9%
Octocrylene - 9.5%

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.
• Flammable. Contents under pressure. Keep away from fire, smoke, other sources of ignition or while smoking. Do not puncture of incinerate can. Do not store above 120 F.
• 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

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Butyloctyl Salicylate, Citrus Paradisi (Grapefruit) Peel Oil, Cladonia Stellaris Extract, Diisopropyl Adipate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Tetrahexyldecyl Ascorbate, Tocopherol

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 70 HYDRATING ANTIOXIDANT SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83046-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALCOHOL (UNII: 3K9958V90M)
ETHYL FERULATE (UNII: 5B8915UELW)
GRAPEFRUIT OIL (UNII: YR377U58W9)
CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83046-370-13	177 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/01/2023

Labeler - Oars and Alps LLC (040241941)