Poolside Orange Creme Spf 30 Sunscreen Oil Mist

Poolside Orange Creme Spf 30 Sunscreen Oil Mist
SPL v1
SPL
SPL Set ID 5a9f8888-529d-40d7-9489-baa5ff657cb4
Route
TOPICAL
Published
Effective Date 2026-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (150 mg) Octocrylene (100 mg) Ethylhexyl Salicylate (50 mg) Avobenzone (30 mg)
Inactive Ingredients
Medium-chain Triglycerides Alcohol Butyloctyl Salicylate Jojoba Oil Grape Seed Oil Sunflower Oil Coconut Oil Shea Butter Bergamot Oil

Identifiers & Packaging

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

Description

Homosalate 15%, Octocrylene 10%, Octisalate 5%, Avobenzone 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 15%, Octocrylene 10%, Octisalate 5%, 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 15%, Octocrylene 10%, Octisalate 5%, Avobenzone 3%

Inactive Ingredients

CAPRYLIC/CAPRIC TRIGLYCERIDE, ALCOHOL DENAT., BUTYLOCTYL SALICYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL.

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 15%, Octocrylene 10%, Octisalate 5%, Avobenzone 3%

Inactive Ingredients (Inactive ingredients)

CAPRYLIC/CAPRIC TRIGLYCERIDE, ALCOHOL DENAT., BUTYLOCTYL SALICYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL.

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

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