POOLSIDE FROSTBITE SUNSCREEN COCONUT SPF 15 SCENTED LIP GLOSS- homosalate, octocrylene, octisalate, avobenzone liquid

Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss by

Drug Labeling and Warnings

Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss by is a Otc medication manufactured, distributed, or labeled by I World LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Homosalate 5%, Octocrylene 4.5%, Octisalate 4%, Avobenzone 3%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Skin cancer/skin aging alert

• Spending time in the sun increases your risk of skin cancer and early skin aging.
• This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 doctor if

• rash occurs.

Keep out of reach of children.

• If product is swallowed get medical help or contact a poison control center right away.

Directions

• Apply generously and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 month: ask a doctor.

Other information

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

Inactive ingredients

POLYISOBUTENE, HYDROGENATED POLYISOBUTENE, VP/HEXADECENE COPOLYMER, OCTYLDODECANOL, MENTHOL, FRAGRANCE, GLYCERYL CAPRYLATE, MENTHOXYPROPANEDIOL, BHT, ALUMINUM HYDROXIDE, WATER, TOCOPHEROL, SODIUM SULFATE, SODIUM CHLORIDE, FD&C BLUE 1 ALUMINUM LAKE (CI 42090).

Questions or comments?

1-212- 244-5170 info@amora.beauty

Package Labeling:

INGREDIENTS AND APPEARANCE

POOLSIDE FROSTBITE SUNSCREEN COCONUT SPF 15 SCENTED LIP GLOSS 
homosalate, octocrylene, octisalate, avobenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85179-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	45 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM SULFATE (UNII: 0YPR65R21J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
OCTYLDODECANOL (UNII: 461N1O614Y)
MENTHOL (UNII: L7T10EIP3A)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85179-023-00	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/17/2025

Labeler - I World LLC (830590126)

Registrant - I World LLC (830590126)