SPL v3
SPL
SPL Set ID 20a60051-d57c-a341-e063-6394a90a9243
Route
TOPICAL
Published
Effective Date 2024-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: oval Color: white Size: 150 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-16

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%

Section 51945-4

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

Warning

​Warning-For external use only

Do Not Use

Do not use on damaged skin, on broken skin

Active Ingredient

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

Incations & Usage

Incations & usage-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

When Using This Product

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

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

Ask A Doctor to Use for Children Under 6 Months

Ask a doctor to use for children under 6 months


Structured Label Content

Section 51945-4 (51945-4)

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

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

Warning

​Warning-For external use only

Do Not Use (Do not use)

Do not use on damaged skin, on broken skin

Active Ingredient

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

Incations & Usage (Incations & usage)

Incations & usage-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

When Using This Product (When using this product)

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

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

Ask A Doctor to Use for Children Under 6 Months (Ask a doctor to use for children under 6 months)

Ask a doctor to use for children under 6 months


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)