1 Oz Spf 8

1 Oz Spf 8
SPL v1
SPL
SPL Set ID 11e8b612-29be-47ed-e063-6394a90ab9e7
Route
TOPICAL
Published
Effective Date 2024-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (10 mg) Octisalate (65 mg) Octinoxate Oxybenzone
Inactive Ingredients
Isopropyl Palmitate Selenicereus Grandiflorus Flower Sunflower Seed Simmondsia Chinensis Seed Ethylhexylglycerin Polysorbate 60 Stearic Acid Glyceryl Stearate Se Peg-100 Stearate Glycerin Dimethicone Rosa Canina Flower Phenoxyethanol Sage Aloe Vera Leaf Stearyl Alcohol Vitamin A Palmitate Titanium Dioxide Water .alpha.-tocopherol Acetate Disodium Edta-copper Lupinus Luteus Seed Hops Trolamine Mullein Leaf Arctium Lappa Root Viscum Album Fruit Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-21

Description

Ethylhexyl Methoxycinnamate (6.50%), Ethylhexyl Salicylate (1.00%), Benzophenone-3 (1.00%), Butyl Methoxydibenzoylmethane (1.00%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Ethylhexyl Methoxycinnamate (6.50%), Ethylhexyl Salicylate (1.00%), Benzophenone-3 (1.00%), Butyl Methoxydibenzoylmethane (1.00%)

Uses

Provides minimal 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 childen under the age of 6 months 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 (6.50%), Ethylhexyl Salicylate (1.00%), Benzophenone-3 (1.00%), Butyl Methoxydibenzoylmethane (1.00%)

Inactive Ingredients

Water, Isopropyl Palmitate, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Dimethicone, Cetearyl Alcohol, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Polysorbate 60, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosa Canina (Rose Hips) Flower 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 (Burdock) Root Extract, Viscum Album (Mistletoe) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Fragrance , Titanium Dioxide

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

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 minimal 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 childen under the age of 6 months 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 (6.50%), Ethylhexyl Salicylate (1.00%), Benzophenone-3 (1.00%), Butyl Methoxydibenzoylmethane (1.00%)

Inactive Ingredients

Water, Isopropyl Palmitate, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Dimethicone, Cetearyl Alcohol, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Polysorbate 60, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosa Canina (Rose Hips) Flower 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 (Burdock) Root Extract, Viscum Album (Mistletoe) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Fragrance , Titanium Dioxide

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)

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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