Protective Day Lotion

Protective Day Lotion
SPL v6
SPL
SPL Set ID 401e53ee-d69d-4ba6-8cbd-8ebfbf6c606e
Route
TOPICAL
Published
Effective Date 2017-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octinoxate (75 mg) Octocrylene (20 mg)
Inactive Ingredients
Water Butylene Glycol Isopropyl Lauroyl Sarcosinate Pentylene Glycol Mica Ethylhexyl Palmitate Cetostearyl Alcohol Dimethicone Polysorbate 60 Soybean Black Olive Watermelon Lens Culinaris Fruit Apple Eleuthero Asian Ginseng American Ginseng Shea Butter Rosa Multiflora Fruit Ceramide Np Sodium Pyrrolidone Carboxylate Glycerin Sodium Lactate Ceteth-10 Phosphate Dihexadecyl Phosphate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Carboxypolymethylene Silicon Dioxide Citric Acid Monohydrate Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-08-01 Until 2026-03-31

Description

Avobenzone 3% Homosalate 10% Octinoxate 7.5% Octocrylene 2%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen





Dosage and Administration

• Shake well and apply a pearl-sized amount to face and neck • Apply generously and evenly 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor









Sun Protection Measures

Description

Avobenzone 3% Homosalate 10% Octinoxate 7.5% Octocrylene 2%

Uses

• Helps Prevent Sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• on damaged or broken skin. • keep out of eyes. Rinse with water to remove. • rash occurs. For External use only. Do not use When using this product Stop use and ask a doctor if





Other Information

• Protect the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3% Homosalate 10% Octinoxate 7.5% Octocrylene 2%





Inactive Ingredients:

Water, Butylene Glycol, Isopropyl Lauroyl Sarcosinate, Pentylene Glycol, Mica, Ethylhexyl Palmitate, Cetearyl Alcohol, Dimethicone, Polysorbate 60, Ocimum Basilicum Hairy Root Culture Extract, Glycine Soja (Soybean) Seed Extract, Olea Europaea (Olive) Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Panax Ginseng Root Extract, Panax Quinquefolius Root Extract, Butyrospermum Parkii (Shea) Butter, Rosa Multiflora Fruit Extract, Ceramide NP, Sodium PCA,Glycerin, Sodium Lactate, Ceteth-10 Phosphate, Dicetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Silica, Hydrolyzed Corn Starch, Citric Acid, Potassium Hydroxide, Fragrance.















































Questions Or Comments?

Call toll free 1-800-950-9595

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• Helps Prevent Sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

• Shake well and apply a pearl-sized amount to face and neck • Apply generously and evenly 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor









Sun Protection Measures

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen





Warnings

• on damaged or broken skin. • keep out of eyes. Rinse with water to remove. • rash occurs. For External use only. Do not use When using this product Stop use and ask a doctor if





Other Information

• Protect the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3% Homosalate 10% Octinoxate 7.5% Octocrylene 2%





Inactive Ingredients:

Water, Butylene Glycol, Isopropyl Lauroyl Sarcosinate, Pentylene Glycol, Mica, Ethylhexyl Palmitate, Cetearyl Alcohol, Dimethicone, Polysorbate 60, Ocimum Basilicum Hairy Root Culture Extract, Glycine Soja (Soybean) Seed Extract, Olea Europaea (Olive) Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Panax Ginseng Root Extract, Panax Quinquefolius Root Extract, Butyrospermum Parkii (Shea) Butter, Rosa Multiflora Fruit Extract, Ceramide NP, Sodium PCA,Glycerin, Sodium Lactate, Ceteth-10 Phosphate, Dicetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Silica, Hydrolyzed Corn Starch, Citric Acid, Potassium Hydroxide, Fragrance.















































Questions Or Comments? (Questions or Comments?)

Call toll free 1-800-950-9595

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

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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