SPL v3
SPL
SPL Set ID 3009df84-4ca7-e170-e063-6294a90a1578
Route
TOPICAL
Published
Effective Date 2025-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4.5 g) Avobenzone (1.35 g) Octisalate (2.25 g)
Inactive Ingredients
Vinylpyrrolidone/eicosene Copolymer Centella Asiatica Triterpenoids Tocopherol 1,3-beta-glucan Synthase Component Fks1 Ammonium Acryloyldimethyltaurate Butylene Glycol Butyloctyl Salicylate Diethylhexyl 2,6-naphthalate Tert-butyl Alcohol Houttuynia Cordata Flowering Top C20-22 Alkyl Phosphate C20-22 Alcohols Silicon Dioxide Xanthan Gum Behenyl Acrylate Polymer Water Propanediol Glyceryl Stearate Se 1,2-hexanediol Pentylene Glycol Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Niacinamide Polymethylsilsesquioxane (11 Microns) Glycerin Tromethamine Adenosine Ethylhexylglycerin Purslane Cetyl Alcohol

Identifiers & Packaging

Pill Appearance
Shape: oval Color: white Size: 150 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-11

Description

Active Ingredient-HOMOSALATE 9%, ETHYLHEXYL SALICYLATE-4.5%, BUTYL METHOXYDIBENZOYLMETHANE-2.7%

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn


Medication Information

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

Description

Active Ingredient-HOMOSALATE 9%, ETHYLHEXYL SALICYLATE-4.5%, BUTYL METHOXYDIBENZOYLMETHANE-2.7%

Uses

Apply Liberally 15 minutes before sun exposure. Reapply at least every two hours, 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 of 15 of higher and other sun protection measures including: 1)Limited time in the sun, especially from 10am to 2pm. 2) Wear Long-sleeve shirts, pants, hats, and sunglasses. Ask a doctor to use for childer under 6 months.For external use only. Do not use on damaged skin & broken skin. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed medical help or contact a Poison Control Center right away

Section 55106-9

Active Ingredient-HOMOSALATE 9%, ETHYLHEXYL SALICYLATE-4.5%, BUTYL METHOXYDIBENZOYLMETHANE-2.7%

Warning

For external use only Do not use on damaged skin & broken skinWhen using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed medical help or contact a Poison Control Center right away

Do Not Use

Do not use on damaged skin, on broken skin

Ask A Doctor

Ask a doctor to use for children under 6 months

Incations & Usage

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.

Purpose Sunscreen

Purpose-Sunscreen, Uses-Helps prevent sunburn

Inactive Ingredients

Inactive Ingredients-WATER, BUTYLOCTYL SALICYLATE, DIETHYLHEXYL 2,6-NAPHTHALATE, BUTYLENE GLYCOL,NIACINAMIDE, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, 1,2-HEXANEDIOL, POLYMETHYLSILSESQUIOXANE, ACRYLATES COPOLYMER, PENTYLENE GLYCOL, CETYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, SILICA, VP/EICOSENE COPOLYMER, GLYCERYL STEARATE, TROMETHAMINE, PROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, XANTHAN GUM, ETHYLHEXYLGLYCERIN, ADENOSINE, PORTULACA OLERACEA EXTRACT, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, T-BUTYL ALCOHOL, TOCOPHEROL, GLYCERIN, BETA-GLUCAN

Dosage & Administration

Dosage & administration -Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Other Safety Information

Other Safety Information-Protect the product in this container from excessive heat and direct sun

Keep Out of Reach of Children

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

Package Label Principal Display Panel

Package Label Principal Display Panel-Thank you Farmer SPF30 Broad Spectrum, Sun Project Soothing Sun Lotion SPF30 Broad Spectrum 1.69FL.OZ/50ML


Structured Label Content

Uses

Apply Liberally 15 minutes before sun exposure. Reapply at least every two hours, 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 of 15 of higher and other sun protection measures including: 1)Limited time in the sun, especially from 10am to 2pm. 2) Wear Long-sleeve shirts, pants, hats, and sunglasses. Ask a doctor to use for childer under 6 months.For external use only. Do not use on damaged skin & broken skin. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed medical help or contact a Poison Control Center right away

Section 55106-9 (55106-9)

Active Ingredient-HOMOSALATE 9%, ETHYLHEXYL SALICYLATE-4.5%, BUTYL METHOXYDIBENZOYLMETHANE-2.7%

Warning

For external use only Do not use on damaged skin & broken skinWhen using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed medical help or contact a Poison Control Center right away

Do Not Use (Do not use)

Do not use on damaged skin, on broken skin

Ask A Doctor (Ask a doctor)

Ask a doctor to use for children under 6 months

Incations & Usage (Incations & usage)

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.

Purpose Sunscreen (Purpose-Sunscreen)

Purpose-Sunscreen, Uses-Helps prevent sunburn

Inactive Ingredients

Inactive Ingredients-WATER, BUTYLOCTYL SALICYLATE, DIETHYLHEXYL 2,6-NAPHTHALATE, BUTYLENE GLYCOL,NIACINAMIDE, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, 1,2-HEXANEDIOL, POLYMETHYLSILSESQUIOXANE, ACRYLATES COPOLYMER, PENTYLENE GLYCOL, CETYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, SILICA, VP/EICOSENE COPOLYMER, GLYCERYL STEARATE, TROMETHAMINE, PROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, XANTHAN GUM, ETHYLHEXYLGLYCERIN, ADENOSINE, PORTULACA OLERACEA EXTRACT, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, T-BUTYL ALCOHOL, TOCOPHEROL, GLYCERIN, BETA-GLUCAN

Dosage & Administration (Dosage & administration)

Dosage & administration -Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Other Safety Information

Other Safety Information-Protect the product in this container from excessive heat and direct sun

Keep Out of Reach of Children (Keep Out Of Reach of Children)

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

Package Label Principal Display Panel

Package Label Principal Display Panel-Thank you Farmer SPF30 Broad Spectrum, Sun Project Soothing Sun Lotion SPF30 Broad Spectrum 1.69FL.OZ/50ML


Advanced Ingredient Data


Raw Label Data

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