SPL v1
SPL
SPL Set ID 300ab1bc-9c11-c2f0-e063-6394a90aa853
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) Octocrylene (2 g) Octisalate (2.25 g) Octinoxate (3.4 g) Avobenzone (1.35 g)
Inactive Ingredients
Glycerin Hydrogenated Soybean Lecithin Ammonium Acryloyldimethyltaurate Butylene Glycol Caprylyl Trisiloxane Medium-chain Triglycerides Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Xanthan Gum Ethylhexylglycerin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Behenyl Acrylate Polymer Pentylene Glycol Caprylyl/capryl Oligoglucoside Sorbitan Oleate Decylglucoside Crosspolymer Polyglyceryl-10 Isostearate Panthenol Butyloctyl Salicylate Cetyl Alcohol Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Water C20-22 Alcohols Adenosine C20-22 Alkyl Phosphate Silicon Dioxide 1,2-hexanediol Polymethylsilsesquioxane (4.5 Microns) Tocopherol Tromethamine Glyceryl Stearate Se Niacinamide Hydrogenated Polyisobutene (1300 Mw) Menadione Dimethiconol (100000 Cst) Trisiloxane Tert-butyl 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 METHOXYCINNAMATE 6.8%, ETHYLHEXYL SALICYLATE 4.5%, OCTOCRYLENE 4%, BUTYL METHOXYDIBENZOYLMETHANE 2.7%

Purpose

Purpose-Sunscreen, Uses-Helps prevent sunburn


Medication Information

Warnings and Precautions

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, get medical help or contact a Poison Control Center right away

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. To Decrease this risk, regularly use a sunscreen with a broad spectrum SP of 15 of higher and other sun protection measures including: 1)Limied 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

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

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 exce ssive heat and direct sun

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

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 away


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 SP of 15 of higher and other sun protection measures including: 1)Limied 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

Warnings and Precautions (34071-1)

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, get medical help or contact a Poison Control Center right away

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

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 exce ssive heat and direct sun

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

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 away


Advanced Ingredient Data


Raw Label Data

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