Poolside Frostbite Sunscreen Papaya Spf 15 Scented Lip Gloss

Poolside Frostbite Sunscreen Papaya Spf 15 Scented Lip Gloss
SPL v1
SPL
SPL Set ID 967d0657-18fc-4e4a-b52d-442df43329f1
Route
TOPICAL
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (50 mg) Octocrylene (45 mg) Ethylhexyl Salicylate (40 mg) Avobenzone (30 mg)
Inactive Ingredients
Tocopherol Sodium Sulfate Sodium Chloride Fd&c Yellow No. 5 Vinylpyrrolidone/hexadecene Copolymer Octyldodecanol Menthol Glyceryl Monocaprylate 3-((l-menthyl)oxy)propane-1,2-diol Butylated Hydroxytoluene Aluminum Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17
Description

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

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

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

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.
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.
Do Not Use
  • on damaged or broken skin.
Drug Facts

Other Information

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

Package Labeling:

Active Ingredients

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

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 YELLOW NO.5 ALUMINUM LAKE (CI 19140).

Questions Or Comments?

1-212- 244-5170 [email protected]

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.

Structured Label Content

Uses

Helps prevent sunburn.

Purpose

Sunscreen

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.
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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Other Information (Other information)

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

Package Labeling:

Active Ingredients (Active ingredients)

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

Inactive Ingredients (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 YELLOW NO.5 ALUMINUM LAKE (CI 19140).

Questions Or Comments? (Questions or comments?)

1-212- 244-5170 [email protected]

When Using This Product (When using this product)
  • keep out of eyes. rinse with water to remove.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • rash occurs.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If product is swallowed get medical help or contact a poison control center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:16.477293 · Updated: 2026-03-14T23:12:26.991151