Spf 45 Spray

Spf 45 Spray
SPL v1
SPL
SPL Set ID 11d54b18-59b2-0d53-e063-6394a90adb02
Route
TOPICAL
Published
Effective Date 2024-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (70 mg) Oxybenzone (50 mg) Avobenzone (30 mg) Octisalate (100 mg) Homosalate Octinoxate
Inactive Ingredients
Alcohol Biotin Aloe Vera Leaf Sage Lupinus Luteus Seed Hops Viscum Album Fruit Rosa Canina Flower Simmondsia Chinensis Seed Arctium Lappa Root .alpha.-tocopherol Acetate Sunflower Seed Panthenol Ppg-12/smdi Copolymer Allantoin Mullein Leaf Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) Vitamin A Palmitate Selenicereus Grandiflorus Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-20

Description

Homosalate (10.00%), Ethylhexyl Methoxycinnamate (7.50%), Octocrylene (7.00%), Ethylhexyl Salicylate (5.00%), Benzophenone-3 (5.00%), Butyl Methoxydibenzoylmethane (Avobenzone) (3.00%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate (10.00%), Ethylhexyl Methoxycinnamate (7.50%), Octocrylene (7.00%), Ethylhexyl Salicylate (5.00%), Benzophenone-3 (5.00%), Butyl Methoxydibenzoylmethane (Avobenzone) (3.00%)

Uses

Provides high sunburn protection. Higher SPF gives more sunburn protection

Section 51945-4

Warnings

For external use only. Do not swallow. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Directions

Apply liberally and evenly to the skin 30 minutes before and during sun exposure. Spray into hands and apply to the face. Avoid contact with eyes. 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

Homosalate (10.00%), Ethylhexyl Methoxycinnamate (7.50%), Octocrylene (7.00%), Ethylhexyl Salicylate (5.00%), Benzophenone-3 (5.00%), Butyl Methoxydibenzoylmethane (Avobenzone) (3.00%)

Inactive Ingredients

SD Alcohol 40B, Acrylates/ Octylacrylamide Copolymer, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Polyol Prepolymer 2, Panthenol, Simmondsia Chinensis (Jojoba) Seed Extract, Biotin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Allantoin, 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, Viscum Album (Mistletoe) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, 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. Do not swallow. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Directions

Apply liberally and evenly to the skin 30 minutes before and during sun exposure. Spray into hands and apply to the face. Avoid contact with eyes. 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

Homosalate (10.00%), Ethylhexyl Methoxycinnamate (7.50%), Octocrylene (7.00%), Ethylhexyl Salicylate (5.00%), Benzophenone-3 (5.00%), Butyl Methoxydibenzoylmethane (Avobenzone) (3.00%)

Inactive Ingredients

SD Alcohol 40B, Acrylates/ Octylacrylamide Copolymer, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Polyol Prepolymer 2, Panthenol, Simmondsia Chinensis (Jojoba) Seed Extract, Biotin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Allantoin, 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, Viscum Album (Mistletoe) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, 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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