fe2148db-9020-9343-e053-6294a90adf70

SPL v5
SPL
SPL Set ID fe2148db-9020-9343-e053-6294a90adf70
Route
topical
Published
Effective Date 2023-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g) octocrylene (27.585 mL)
Inactive Ingredients
water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-07-31

Description

Directions ■ Apply liberally 15 minutes before sun exposure. ■ Children under 6 months of age: Ask a doctor. ■ Reapply at least every 2 hours. ■ Use a water-resistant sunscreen if swimming or sweating. ■ Sun Protection Measures. 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. ■ See Outer Package for complete Drug Facts.


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8.7%

Indications and Usage

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

Directions

■ Apply liberally 15 minutes before sun exposure.

■ Children under 6 months of age: Ask a doctor.

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating.

Sun Protection Measures. 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.

■ See Outer Package for complete Drug Facts.

Description

Directions ■ Apply liberally 15 minutes before sun exposure. ■ Children under 6 months of age: Ask a doctor. ■ Reapply at least every 2 hours. ■ Use a water-resistant sunscreen if swimming or sweating. ■ Sun Protection Measures. 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. ■ See Outer Package for complete Drug Facts.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Cetearyl Alcohol, Dipropylene Glycol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polymethylsilsesquioxane, Niacinamide, Benzyl Glycol, Glyceryl Stearate SE, Butylene Glycol, Panthenol, Arginine, Carbomer, Brassica Oleracea Italica (Broccoli) Extract, Melaleuca Alternifolia [Tea Tree) Leaf Extract, Hydroxypropyl Methylcellulose Stearoxy Ether, Centella Asiatica Extract, Camellia Sinensis Leaf Water, Tocopherol, Disodium EDTA, Ethylhexylglycerin, Xanthan Gum, Adenosine, 1,2-Hexanediol, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Lonicera Caprifolium (Honeysuckle] Extract, Yeast Extract, Limonia Acidissima Extract, Sodium Hyaluronate, Propanediol, Sodium Hyaluronate Crosspolymer, Ascorbyl Propyl Hyaluronate, Hydrolyzed Glycosaminoglycans, Glycerin, Madecassic Acid, Asiaticoside, Asiatic Acid, Caprylyl Glycol, Sodium Ascorbyl Phosphate, Hydrolyzed Hyaluronic Acid, Hyaluronic Acid, Biotin, Cyanocobalamin, Ascorbic Acid, Folic Acid, Thiamine HCI, Riboflavín, Pyridoxine, Fragrance, Citral, Benzyl Salicylate, Linalool, Limonene

Section 51945-4

Section 55105-1

Sunscreen

Section 59845-8

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.

Section 60561-8

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

■ Sun alert: Limitng sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8.7%

Indications and Usage (34067-9)

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)

Directions

■ Apply liberally 15 minutes before sun exposure.

■ Children under 6 months of age: Ask a doctor.

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating.

Sun Protection Measures. 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.

■ See Outer Package for complete Drug Facts.

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Cetearyl Alcohol, Dipropylene Glycol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polymethylsilsesquioxane, Niacinamide, Benzyl Glycol, Glyceryl Stearate SE, Butylene Glycol, Panthenol, Arginine, Carbomer, Brassica Oleracea Italica (Broccoli) Extract, Melaleuca Alternifolia [Tea Tree) Leaf Extract, Hydroxypropyl Methylcellulose Stearoxy Ether, Centella Asiatica Extract, Camellia Sinensis Leaf Water, Tocopherol, Disodium EDTA, Ethylhexylglycerin, Xanthan Gum, Adenosine, 1,2-Hexanediol, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Lonicera Caprifolium (Honeysuckle] Extract, Yeast Extract, Limonia Acidissima Extract, Sodium Hyaluronate, Propanediol, Sodium Hyaluronate Crosspolymer, Ascorbyl Propyl Hyaluronate, Hydrolyzed Glycosaminoglycans, Glycerin, Madecassic Acid, Asiaticoside, Asiatic Acid, Caprylyl Glycol, Sodium Ascorbyl Phosphate, Hydrolyzed Hyaluronic Acid, Hyaluronic Acid, Biotin, Cyanocobalamin, Ascorbic Acid, Folic Acid, Thiamine HCI, Riboflavín, Pyridoxine, Fragrance, Citral, Benzyl Salicylate, Linalool, Limonene

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 59845-8 (59845-8)

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.

Section 60561-8 (60561-8)

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

■ Sun alert: Limitng sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.


Advanced Ingredient Data


Raw Label Data

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