14a85a88-c9a2-94ea-e063-6394a90a4e14
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts Active Ingredients Purpose Zinc Oxide (20.00%)......Sunscreen
Medication Information
Warnings and Precautions
Warnings:
• For external use only.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to
remove.
• Stop use and ask a doctor if rash occurs.
• Keep out of reach of children. If product is swallowed, get
medical help or contact a Poison Control Center right away.
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 10am - 2pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Indications and Usage
Uses:
• Helps prevent sunburn.
Directions:
• Apply generously and evenly 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
Dosage and Administration
Dosage: Evenly and generously apply to skin.
Administration: Topical
Description
Drug Facts Active Ingredients Purpose Zinc Oxide (20.00%)......Sunscreen
Section 50565-1
Keep out of reach of children.
Section 51727-6
Aqua (Water, Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius Oleosomes, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Diisooctyl Succinate, Dimethicone, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Euterpe Oleracea (Açaí) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Isononyl Isononanoate, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Microcrystalline Cellulose, Niacinamide, Parfum (Fragrance), Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Grandiflorum (Cupuaçu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, Benzyl Salicylate, Citronellol, Limonene.
Section 51945-4
Section 55105-1
Sunscreen
Section 55106-9
Drug Facts
Active Ingredients Purpose
Zinc Oxide (20.00%)......Sunscreen
Structured Label Content
Indications and Usage (34067-9)
Uses:
• Helps prevent sunburn.
Directions:
• Apply generously and evenly 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
Dosage and Administration (34068-7)
Dosage: Evenly and generously apply to skin.
Administration: Topical
Warnings and Precautions (34071-1)
Warnings:
• For external use only.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to
remove.
• Stop use and ask a doctor if rash occurs.
• Keep out of reach of children. If product is swallowed, get
medical help or contact a Poison Control Center right away.
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 10am - 2pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 51727-6 (51727-6)
Aqua (Water, Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius Oleosomes, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Diisooctyl Succinate, Dimethicone, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Euterpe Oleracea (Açaí) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Isononyl Isononanoate, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Microcrystalline Cellulose, Niacinamide, Parfum (Fragrance), Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Grandiflorum (Cupuaçu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, Benzyl Salicylate, Citronellol, Limonene.
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Sunscreen
Section 55106-9 (55106-9)
Drug Facts
Active Ingredients Purpose
Zinc Oxide (20.00%)......Sunscreen
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:02:58.213076 · Updated: 2026-03-14T23:02:48.423363