32 Oz Water Resistant Spf 30

32 Oz Water Resistant Spf 30
SPL v1
SPL
SPL Set ID 11334e45-4bc2-d597-e063-6294a90a323e
Route
TOPICAL
Published
Effective Date 2024-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-12

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 highl 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 Use 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 highl 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 Use and Ask A Doctor If (Stop use 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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