SPL v3
SPL
SPL Set ID 20a83f02-d851-4aac-e063-6394a90ae1a6
Route
TOPICAL
Published
Effective Date 2024-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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 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%

Section 51945-4

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

Warning

Warning-For external use only

Do Not Use

Do not use on damaged skin, on broken skin

When Using

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

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%

Incations & Usage

Incations & usage-Helps prevent sunburn

Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, BUTYLENE GLYCOL, ACRYLATES COPOLYMER, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, GLYCERIN, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL,CETYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, TROMETHAMINE, GLYCERYL 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

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- If product is swallowed, get medical help or contact a Poison Control Center right away

Structured Label Content

Section 51945-4 (51945-4)

Package Label Principal Display Panel-Thank you Farmer, SPF40 Broad Spectrum, Sun Project Moisture Sun Creaml Sinscren, SPF40 Broad Spectrum, 1.69 FL.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

When Using (When using)

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

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%

Incations & Usage (Incations & usage)

Incations & usage-Helps prevent sunburn

Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, BUTYLENE GLYCOL, ACRYLATES COPOLYMER, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, GLYCERIN, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL,CETYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, TROMETHAMINE, GLYCERYL 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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:12.513305 · Updated: 2026-03-14T23:12:23.079612