Oars & Alps SPF 18 Shine Free Lip Balm

Oars and Alps SPF 18 Shine Free Lip Balm by

Drug Labeling and Warnings

Oars and Alps SPF 18 Shine Free Lip Balm 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 18 SHINE FREE LIP BALM- avobenzone, octisalate, octocrylene stick 
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 18 Shine Free Lip Balm

Avobenzone – 2.9%

Octisalate – 4.0%

Octocrylene – 2.4%

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.

Do not store at temperatures above 120 F.

For external use only.
Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.
When using this product: keep out of eyes. Rinse with water to remove.

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.
• At least every 2 hours.
• 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.

Beeswax, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calcium Sodium Borosilicate, Cladonia Stellaris Extract, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Macadamia Integrifolia Seed Oil, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Stevia Rebaudiana Extract, Tapioca Starch, Tocopherol

Other Information

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

OARS AND ALPS SPF 18 SHINE FREE LIP BALM 
avobenzone, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83046-373
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 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
MACADAMIA OIL (UNII: 515610SU8C)
SPEARMINT OIL (UNII: C3M81465G5)
STARCH, TAPIOCA (UNII: 24SC3U704I)
TOCOPHEROL (UNII: R0ZB2556P8)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEPPERMINT OIL (UNII: AV092KU4JH)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83046-373-01	3 in 1 PACKAGE	07/01/2021
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	07/01/2021

Labeler - Oars and Alps LLC (040241941)

Revised: 12/2022

Document Id: eedc8625-f678-f7dd-e053-2995a90a8b4b

34390-5

Set id: eedc068a-e88e-23de-e053-2a95a90a47f5

Version: 2

Effective Time: 20221202