73071-102

73071-102
SPL v2
SPL
SPL Set ID 48406e68-eefd-d2c2-e063-6394a90a4ad9
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9.9 g) Homosalate (7.3 g) Octisalate (4.9 g) Zinc Oxide (7.04 g)
Inactive Ingredients
Niacinamide Methylpropanediol Polyglyceryl-6 Oleate Helianthus Annuus (sunflower) Seed Oil Thiamine Hcl Palmitoyl Tetrapeptide-7 Riboflavin Cyanocobalamin Ascorbic Acid Pyridoxine Water Butylene Glycol Polyglyceryl-10 Myristate Potassium Cetyl Phosphate Rosmarinus Officinalis (rosemary) Leaf Powder Cocos Nucifera (coconut) Oil Palmitoyl Tripeptide-1 Coco-caprylate/caprate Glyceryl Monoundecylenate Folic Acid Biotin Hydrolyzed Porcine Collagen (enzymatic; 3000 Mw) Sodium Ascorbyl Phosphate Glycerin Copper Tripeptide-1 Ethylhexyl Palmitate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Paraffin Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Caprylic/capric Triglyceride Dibutyl Adipate Butyloctyl Salicylate Crambe Abyssinica Seed Oil 1,2-hexanediol Bisabolol Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-4 Oleate Pyrus Communis (pear) Fruit Triethoxycaprylylsilane .alpha.-tocopherol, Dl- Rosa Damascena Flower Oil Ethylhexylglycerin Iris Florentina Root Muskmelon Hedera Helix Leaf Lithospermum Erythrorhizon Root Chamomile Flower Oil Beta Carotene Lutein

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15
Description

Homosalate 7.3% Octisalate 4.9% Octocrylene 9.9% Zinc Oxide 7.04%

Medication Information

Warnings and Precautions

• For external use only.

Indications and 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.

Dosage and Administration

Directions

■ Apply liberally 15 minutes before sun exposure. ■ Reapply at least every 2 hours. ■ Children under 6 months of age: Ask a doctor. ■ 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 value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses.

Description

Homosalate 7.3% Octisalate 4.9% Octocrylene 9.9% Zinc Oxide 7.04%

Section 50565-1

■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Section 50566-9

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7

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

Section 50570-1

Do not use ■ on damaged or broken skin.

Section 51727-6

Ethylhexyl Palmitate, Methyl Methacrylate Crosspolymer, Synthetic Wax, Vinyl Dimethi cone/Methicone Silsesquiox ane Crosspolymer, Caprylic/ Capric Triglyceride, Dibutyl Adipate, Butyloctyl Salicylat e, Crambe Abyssinica Seed Oil, 1,2-Hexanediol, Alpha-Bi sabolol, Polyhydroxystearic Acid, Polyglyceryl-4 Oleate, Pyrus Communis (Pear) Fruit Extract, Triethoxycaprylylsil ane, Tocopherol, Polyglycer yl-6 Oleate, Rosa Damascena Flower Water, Ethylhexylgly cerin, Iris Florentina Root Ex tract, Cucumis Melo (Melon) Fruit Extract, Hedera Helix (I vy) Leaf/Stem Extract, Beta -Carotene, Xanthophylls, Ro smarinus Officinalis (Rosema ry) Leaf Extract, Water, Glyc erin, Calamine, Butylene Gly col, Polyglyceryl-10 Myristat e, Hydrolyzed Extensin, Pot assium Cetyl Phosphate, Co cos Nucifera (Coconut) Oil, Methylpropanediol, Glycer yl Undecylenate, Coco-Cap rylate/Caprate, Copper T ripeptide-1, Palmitoyl Tetra peptide-7, Palmitoyl Tripep tide-1, Niacinamide, Sodium Ascorbyl Phosphate, Folic Acid, Thiamine HCl, Ribofla vin, Pyridoxine, Cyanocoba lamin, Biotin, Ascorbic Acid, Lactobacillus Ferment Ly sate, Lithospermum Erythro rhizon Root Extract, Chamo milla Recutita (Matricaria) Flower Oil, Helianthus Ann uus (Sunflower) Seed Oil

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 7.3%

Octisalate 4.9%

Octocrylene 9.9%

Zinc Oxide 7.04%

Section 60561-8

■ protect this product in this container from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

■ 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.

Dosage and Administration (34068-7)

Directions

■ Apply liberally 15 minutes before sun exposure. ■ Reapply at least every 2 hours. ■ Children under 6 months of age: Ask a doctor. ■ 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 value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

• For external use only.

Section 50565-1 (50565-1)

■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use ■ on damaged or broken skin.

Section 51727-6 (51727-6)

Ethylhexyl Palmitate, Methyl Methacrylate Crosspolymer, Synthetic Wax, Vinyl Dimethi cone/Methicone Silsesquiox ane Crosspolymer, Caprylic/ Capric Triglyceride, Dibutyl Adipate, Butyloctyl Salicylat e, Crambe Abyssinica Seed Oil, 1,2-Hexanediol, Alpha-Bi sabolol, Polyhydroxystearic Acid, Polyglyceryl-4 Oleate, Pyrus Communis (Pear) Fruit Extract, Triethoxycaprylylsil ane, Tocopherol, Polyglycer yl-6 Oleate, Rosa Damascena Flower Water, Ethylhexylgly cerin, Iris Florentina Root Ex tract, Cucumis Melo (Melon) Fruit Extract, Hedera Helix (I vy) Leaf/Stem Extract, Beta -Carotene, Xanthophylls, Ro smarinus Officinalis (Rosema ry) Leaf Extract, Water, Glyc erin, Calamine, Butylene Gly col, Polyglyceryl-10 Myristat e, Hydrolyzed Extensin, Pot assium Cetyl Phosphate, Co cos Nucifera (Coconut) Oil, Methylpropanediol, Glycer yl Undecylenate, Coco-Cap rylate/Caprate, Copper T ripeptide-1, Palmitoyl Tetra peptide-7, Palmitoyl Tripep tide-1, Niacinamide, Sodium Ascorbyl Phosphate, Folic Acid, Thiamine HCl, Ribofla vin, Pyridoxine, Cyanocoba lamin, Biotin, Ascorbic Acid, Lactobacillus Ferment Ly sate, Lithospermum Erythro rhizon Root Extract, Chamo milla Recutita (Matricaria) Flower Oil, Helianthus Ann uus (Sunflower) Seed Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 7.3%

Octisalate 4.9%

Octocrylene 9.9%

Zinc Oxide 7.04%

Section 60561-8 (60561-8)

■ protect this product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:19.363720 · Updated: 2026-03-14T23:12:31.383435