1 Oz Water Resistant Spf 30

1 Oz Water Resistant Spf 30
SPL v1
SPL
SPL Set ID 115b4d4c-51f1-ad62-e063-6294a90a3e53
Route
TOPICAL
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Homosalate (75 mg) Octinoxate (30 mg) Oxybenzone Avobenzone
Inactive Ingredients
Water .alpha.-tocopherol Acetate Simmondsia Chinensis Seed Selenicereus Grandiflorus Flower Phenoxyethanol Ethylhexylglycerin Sunflower Seed Lupinus Luteus Seed Vitamin A Palmitate Polysorbate 60 Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Stearyl Alcohol Disodium Edta-copper Rosa Canina Flower Arctium Lappa Root Cyclomethicone 7 Cyclomethicone 6 Alkyl (c12-15) Benzoate Trolamine Vinylpyrrolidone/eicosene Copolymer Hops Viscum Album Fruit Lanolin Sage Mullein Leaf Peg-100 Stearate Aloe Vera Leaf Dimethicone Glyceryl Stearate Se

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-14
Description

Ethylhexyl Methoxycinnamate (7.50%), Ethylhexyl Salicylate (5.00%), Homosalate (5.00%), Benzophenone-3 (3.00%), Butyl Methoxydibenzoylmethane (3.00%)

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Ethylhexyl Methoxycinnamate (7.50%), Ethylhexyl Salicylate (5.00%), Homosalate (5.00%), Benzophenone-3 (3.00%), Butyl Methoxydibenzoylmethane (3.00%)

Uses

Provides high sunburn protection. Higher SPF gives more sunburn protection.

Section 51945-4

Warnings

For external use only.

Directions

Apply liberally and evenly to the skin 30 minutes before and during sun exposure. Reapply as needed or after towel drying, perspiring, swimming, and vigorous activities. Use on children under six months of age only wih the advise of a physician.

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using suscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

Active Ingredients

Ethylhexyl Methoxycinnamate (7.50%), Ethylhexyl Salicylate (5.00%), Homosalate (5.00%), Benzophenone-3 (3.00%), Butyl Methoxydibenzoylmethane (3.00%)

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Stearic Acid, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, VP/ Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosa Canina Flower (Rose Hips) Extract, Salvia Officinalis (Sage) Leaf Extract, Verbascum Thapsus (Mullein) Extract, Lupinus Luteus Seed (Lupin) Extract, Humulus Lupulus (Hops) Extract, Cereus Grandiflorus (Cactus) Extract, Arctium Lappa Root (Burdock) Extract, Visicum Album (Mistletoe) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Lanolin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Phenoxyethanol

Ethylhexylglycerin, Fragrance.

Questions Or Comments?

Call toll free 1-800-442-4786

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop and Ask A Doctor If

rash or irritation develops and lasts.

Keep Out of the Reach of Children.

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

Structured Label Content

Uses

Provides high sunburn protection. Higher SPF gives more sunburn protection.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only.

Directions

Apply liberally and evenly to the skin 30 minutes before and during sun exposure. Reapply as needed or after towel drying, perspiring, swimming, and vigorous activities. Use on children under six months of age only wih the advise of a physician.

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using suscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

Active Ingredients

Ethylhexyl Methoxycinnamate (7.50%), Ethylhexyl Salicylate (5.00%), Homosalate (5.00%), Benzophenone-3 (3.00%), Butyl Methoxydibenzoylmethane (3.00%)

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Stearic Acid, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, VP/ Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosa Canina Flower (Rose Hips) Extract, Salvia Officinalis (Sage) Leaf Extract, Verbascum Thapsus (Mullein) Extract, Lupinus Luteus Seed (Lupin) Extract, Humulus Lupulus (Hops) Extract, Cereus Grandiflorus (Cactus) Extract, Arctium Lappa Root (Burdock) Extract, Visicum Album (Mistletoe) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Lanolin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Phenoxyethanol

Ethylhexylglycerin, Fragrance.

Questions Or Comments? (Questions or Comments?)

Call toll free 1-800-442-4786

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop and Ask A Doctor If (Stop and ask a doctor if)

rash or irritation develops and lasts.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.629902 · Updated: 2026-03-14T23:02:32.213463