Drug Facts
13b5c78c-f950-699b-e063-6294a90a9898
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients Homosalate 5.0% Octisalate 5.0% Zinc Oxide 9.3%
Medication Information
Warnings and Precautions
Warnings • For external use only
Indications and Usage
Uses • 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 generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 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 SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses
Description
Active ingredients Homosalate 5.0% Octisalate 5.0% Zinc Oxide 9.3%
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
Inactive ingredients: Aqua/water/Eau, Cyclopentasiloxane, Polyhydroxystearic Acid, Dimethicone, Coconut Alkanes, Stearic Acid, Lecithin, Aloe Barbadensis Leaf Juice, Isohexadecane, lsododecane, Magnesium Sulfate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polysillcone-11, Coco-Caprylate/Caprate, Dimethicone/PEG-10/15 Crosspolymer, Dipropylene Glycol, Sodium Citrate, Tocopherol, Cetearyl Olivate, Sorbitan Olivate, Sodium Hyaluronate, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Sorbitan Isostearate, Caprylyl Glycol, Ethylhexylycerin, Hexylene Glycol, Phosphatidylcholine, Mannitol, Glycerin, Methylpropanediol, Caprylic/Capric Triglyceride, Ectoine, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Vanilla Planifolia Fruit Extract, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Acetyl Zingerone, Camellia Sinensis Leaf Extract, Sodium Benzoate, Potassium Sorbate, Octyldodecanol, Sorbitan Oleate, CI 77491, CI 77492
Section 51945-4
Section 55105-1
Purpose: Sunscreen
Section 55106-9
Active ingredients
Homosalate 5.0%
Octisalate 5.0%
Zinc Oxide 9.3%
Section 60561-8
Other information • protect the product in this container from excessive heat and direct sun
Structured Label Content
Indications and Usage (34067-9)
Uses • 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 generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 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 SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses
Warnings and Precautions (34071-1)
Warnings • 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 right away.
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)
Inactive ingredients: Aqua/water/Eau, Cyclopentasiloxane, Polyhydroxystearic Acid, Dimethicone, Coconut Alkanes, Stearic Acid, Lecithin, Aloe Barbadensis Leaf Juice, Isohexadecane, lsododecane, Magnesium Sulfate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polysillcone-11, Coco-Caprylate/Caprate, Dimethicone/PEG-10/15 Crosspolymer, Dipropylene Glycol, Sodium Citrate, Tocopherol, Cetearyl Olivate, Sorbitan Olivate, Sodium Hyaluronate, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Sorbitan Isostearate, Caprylyl Glycol, Ethylhexylycerin, Hexylene Glycol, Phosphatidylcholine, Mannitol, Glycerin, Methylpropanediol, Caprylic/Capric Triglyceride, Ectoine, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Vanilla Planifolia Fruit Extract, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Acetyl Zingerone, Camellia Sinensis Leaf Extract, Sodium Benzoate, Potassium Sorbate, Octyldodecanol, Sorbitan Oleate, CI 77491, CI 77492
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose: Sunscreen
Section 55106-9 (55106-9)
Active ingredients
Homosalate 5.0%
Octisalate 5.0%
Zinc Oxide 9.3%
Section 60561-8 (60561-8)
Other information • protect the product in this container from excessive heat and direct sun
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:51.849840 · Updated: 2026-03-14T23:02:39.250584