800e4a24-0172-e2a6-e053-2991aa0a7637

SPL v1
SPL
SPL Set ID 800e4a24-0172-e2a6-e053-2991aa0a7637
Route
topical
Published
Effective Date 2018-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) oxybenzone (6 g) octocrylene (10 g)
Inactive Ingredients
edetic acid carboxypolymethylene matricaria recutita leaf phenoxyethanol dimethicone 200 aloe vera leaf glyceryl caprylate vinylpyrrolidone/eicosene copolymer water onion sorbitol polyester-7 sorbitan isostearate lecithin, soybean allantoin .alpha.-tocopherol stearic acid garden cress sprout glycerin neopentyl glycol diheptanoate polyglyceryl-3 distearate polysorbate 80 trolamine jojoba oil benzyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-01-07
Purpose

Sunscreen

Description

Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

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 and early skin aging.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

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 months: ask a doctor.

Inactive Ingredients

Water, Allium Cepa (Onion) Bulb Extract, Sorbitan Isostearate, Sorbitol, Polyester-7, VP/Eicosene Copolymer, Glyceryl Caprylate, decolorized Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Lepidium Sativum (Cress) Sprout Extract, Allantoin, Tocopherol, Stearic Acid, Polysorbate 80, Carbomer, Dimethicone, Disodium EDTA, Lecithin, Glycerin, Neopentyl Glycol Diheptanoate, Polyglyceryl-3 Distearate, Benzyl Alcohol, Triethanolamine, Phenoxyethanol

Description

Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

Label

Active Ingredients

Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

Keep Out of Reach of Children.

If 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 and early skin aging.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

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 months: ask a doctor.

Inactive Ingredients

Water, Allium Cepa (Onion) Bulb Extract, Sorbitan Isostearate, Sorbitol, Polyester-7, VP/Eicosene Copolymer, Glyceryl Caprylate, decolorized Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Lepidium Sativum (Cress) Sprout Extract, Allantoin, Tocopherol, Stearic Acid, Polysorbate 80, Carbomer, Dimethicone, Disodium EDTA, Lecithin, Glycerin, Neopentyl Glycol Diheptanoate, Polyglyceryl-3 Distearate, Benzyl Alcohol, Triethanolamine, Phenoxyethanol

Label

Active Ingredients

Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

Keep Out of Reach of Children.

If 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: 2026-02-15T11:56:44.732080 · Updated: 2026-03-14T22:55:24.290889