OARS AND ALPS SPF 50 HYDRATING ANTIOXIDANT SUNSCREENSPRAY- avobenzone, homosalate, octisalate, octocrylene spray

Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSpray by

Drug Labeling and Warnings

Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSpray 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

Alcohol Denat., Butyloctyl Salicylate, Citrus Paradisi (Grapefruit) Peel Oil, Cladonia Stellaris Extract, Dicaprylyl Carbonate, Diisopropyl Adipate, Ethyl Ferulate, Ethyl Olivate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isodecyl Neopentanoate, Olea Europaea (Olive) Leaf Extract, Tetrahexyldecyl Ascorbate, Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

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 50 HYDRATING ANTIOXIDANT SUNSCREENSPRAY 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83046-360
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)
ETHYL OLIVATE (UNII: KKJ108Y20W)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
VINYL ACETATE (UNII: L9MK238N77)
ALCOHOL (UNII: 3K9958V90M)
ETHYL FERULATE (UNII: 5B8915UELW)
GRAPEFRUIT OIL (UNII: YR377U58W9)
CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83046-360-13	177 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2021
2	NDC: 83046-360-14	55 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	01/01/2021

Labeler - Oars and Alps LLC (040241941)