SPL v2
SPL
SPL Set ID 300d8526-0daf-2255-e063-6394a90a21b1
Route
TOPICAL
Published
Effective Date 2025-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.4 g) Octisalate (2.25 g) Homosalate (4.5 g) Octocrylene (2 g) Avobenzone (1.35 g)
Inactive Ingredients
Glycerin Caprylyl Trisiloxane Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Tromethamine Tocopherol Niacinamide Dimethiconol (100000 Cst) C20-22 Alkyl Phosphate Ammonium Acryloyldimethyltaurate Butylene Glycol Adenosine Tert-butyl Alcohol Water C20-22 Alcohols Hydrogenated Polyisobutene (1300 Mw) Xanthan Gum Polyglyceryl-10 Isostearate 1,2-hexanediol Cetyl Alcohol Caprylyl/capryl Oligoglucoside Polymethylsilsesquioxane (4.5 Microns) Ethylhexylglycerin Sorbitan Oleate Decylglucoside Crosspolymer Hydrogenated Soybean Lecithin Menadione Glyceryl Stearate Se Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Silicon Dioxide Butyloctyl Salicylate Trisiloxane Medium-chain Triglycerides Panthenol Behenyl Acrylate Polymer Pentylene Glycol

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 METHOXYCINNAMATE 6.8%, ETHYLHEXYL SALICYLATE 4.5%, OCTOCRYLENE 4%, 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 METHOXYCINNAMATE 6.8%, ETHYLHEXYL SALICYLATE 4.5%, OCTOCRYLENE 4%, 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. 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 sleeve shirts, pants, hats, and sunglasses. When using this product, keep eyes. with water to remove. If product is swallowed medical help or contact a Poison Control Center right away. When using this product, keep out of eyes. Rinse with water to remove.

Section 51945-4

Package Label Principal Display Panel-Thank you Farmer, SPF40 Broad Spectrum. Sun Project Moisture Sun Cream Sunscreen, SPF40 Broad Spectrum, 1.69 FL.OZ/50ml

Warnings

For external use only. Do not use on damaged skin & broken skin.

Ask A Doctor

Ask a doctor to use for children under 6 months

Active Ingredient

Active Ingredient:HOMOSALATE 9%, ETHYLHEXYL METHOXYCINNAMATE 6.8%, ETHYLHEXYL SALICYLATE 4.5%, OCTOCRYLENE 4%, BUTYL METHOXYDIBENZOYLMETHANE 2.7%

Other Information

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

Indications & Usage

Indications & 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

Inactive Ingredients

Inactive Ingredients-WATER, BUTYLOCTYL SALICYLATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, BUTYLENE GLYCOL, ACRYLATES COPOLYMER, C20-22 ALKYL PHOSPHATE, C2 ALCOHOLS, GLYCERIN, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL,CETYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, TROMETHAMINE, GLYC STEARATE, SILICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONOL, TRISILOXANE, POLYACRYLATE CROSSPOLYMER-6, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,POLYISOBUTENE, ETHYLHEXYLGLYCERIN, ADENOSINE, XANTHAN GUM, CAPRYLYL/CAPRYL GLUCOSIDE, SORBITAN OLEATE, T-BUTYL ALCOHOL, PANTHENOL, TOCOPHEROL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYGLYCERYL-10 DIISOSTEARATE, HYDROGENATED LECITHIN ,MENADIONE

Dosage & Administration

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

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 awa


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. 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 sleeve shirts, pants, hats, and sunglasses. When using this product, keep eyes. with water to remove. If product is swallowed medical help or contact a Poison Control Center right away. When using this product, keep out of eyes. Rinse with water to remove.

Section 51945-4 (51945-4)

Package Label Principal Display Panel-Thank you Farmer, SPF40 Broad Spectrum. Sun Project Moisture Sun Cream Sunscreen, SPF40 Broad Spectrum, 1.69 FL.OZ/50ml

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn

Warnings

For external use only. Do not use on damaged skin & broken skin.

Ask A Doctor (Ask a doctor)

Ask a doctor to use for children under 6 months

Active Ingredient

Active Ingredient:HOMOSALATE 9%, ETHYLHEXYL METHOXYCINNAMATE 6.8%, ETHYLHEXYL SALICYLATE 4.5%, OCTOCRYLENE 4%, BUTYL METHOXYDIBENZOYLMETHANE 2.7%

Other Information

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

Indications & Usage

Indications & 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

Inactive Ingredients

Inactive Ingredients-WATER, BUTYLOCTYL SALICYLATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, BUTYLENE GLYCOL, ACRYLATES COPOLYMER, C20-22 ALKYL PHOSPHATE, C2 ALCOHOLS, GLYCERIN, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL,CETYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, TROMETHAMINE, GLYC STEARATE, SILICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONOL, TRISILOXANE, POLYACRYLATE CROSSPOLYMER-6, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,POLYISOBUTENE, ETHYLHEXYLGLYCERIN, ADENOSINE, XANTHAN GUM, CAPRYLYL/CAPRYL GLUCOSIDE, SORBITAN OLEATE, T-BUTYL ALCOHOL, PANTHENOL, TOCOPHEROL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYGLYCERYL-10 DIISOSTEARATE, HYDROGENATED LECITHIN ,MENADIONE

Dosage & Administration (Dosage & administration)

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

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 awa


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)