poolside frostbite sunscreen watermelon spf 15 scented lip gloss

poolside frostbite sunscreen watermelon spf 15 scented lip gloss
SPL v2
SPL
SPL Set ID 42c8fd50-73c6-480b-9d7e-31157e586929
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
vinylpyrrolidone/hexadecene copolymer octyldodecanol menthol glyceryl monocaprylate 3-((l-menthyl)oxy)propane-1,2-diol butylated hydroxytoluene aluminum hydroxide water tocopherol sodium sulfate sodium chloride d&c red no. 28

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-17
Purpose

Sunscreen

Description

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

Medication Information

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.
Uses

Helps prevent sunburn.

Purpose

Sunscreen

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, D&C RED NO.28 ALUMINUM LAKE (CI 45410).

Description

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

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

Package Labeling:

Active Ingredients

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

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

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.
Uses

Helps prevent sunburn.

Purpose

Sunscreen

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 (Other information)

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

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, D&C RED NO.28 ALUMINUM LAKE (CI 45410).

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

Package Labeling:

Active Ingredients (Active ingredients)

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

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: 2026-02-15T12:08:16.524965 · Updated: 2026-03-14T23:12:26.991151