very emollient daily shade spf 15

very emollient daily shade spf 15
SPL v11
SPL
SPL Set ID 8eeb25a8-337d-c71b-e053-2995a90a091a
Route
topical
Published
Effective Date 2019-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (7.5 g) octisalate (5 g) octocrylene (3 g) avobenzone (2 g)
Inactive Ingredients
polysorbate 60 jojoba oil dehydroacetic acid lecithin, soybean lactic acid alcohol butylphenyl methylpropional echinacea angustifolia safflower oil cetyl alcohol dimethicone 100 aloe vera leaf green tea leaf coumarin glyceryl stearate se benzyl alcohol hydroxyisohexyl 3-cyclohexene carboxaldehyde lavandula angustifolia whole shea butter hydrogenated palm kernel oil phenoxyethanol xanthan gum grape seed oil panthenol glycolic acid allantoin limonene, (+/-)- avocado oil glycerin water sesame oil potassium hydroxide ascorbic acid .alpha.-hexylcinnamaldehyde, (2e)- .alpha.-amylcinnamaldehyde geraniol linalool, (+/-)- salicylic acid matricaria chamomilla cucumber potassium sorbate sodium benzoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2019-07-01

Description

Avobenzone 2.5% Homosalate 7.5% Octisalate 5.0% Octocrylene 3.0%


Medication Information

Warnings and Precautions

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

Active Ingredient

Avobenzone 2.5%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 3.0%

Indications and Usage

For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other protective measures, including: limit time in sun, especially 10am-2pm, and wear long-sleeved shirts, pants, hats and sunglasses.

Dosage and Administration

For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor.

Description

Avobenzone 2.5% Homosalate 7.5% Octisalate 5.0% Octocrylene 3.0%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water (Aqua), Glycerin, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Ascorbic Acid, Panthenol, Tocopheryl Acetate, Allantoin, Citric Acid, Glycolic Acid, Lactic Acid, Lecithin, Polysorbate 60, Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Geraniol, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum)

Section 51945-4

Section 55105-1

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

Avobenzone 2.5%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 3.0%

Indications and Usage (34067-9)

For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other protective measures, including: limit time in sun, especially 10am-2pm, and wear long-sleeved shirts, pants, hats and sunglasses.

Dosage and Administration (34068-7)

For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water (Aqua), Glycerin, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Ascorbic Acid, Panthenol, Tocopheryl Acetate, Allantoin, Citric Acid, Glycolic Acid, Lactic Acid, Lecithin, Polysorbate 60, Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Geraniol, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen


Advanced Ingredient Data


Raw Label Data

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