323661a6-3602-1ce2-e063-6394a90a8e91
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Zinc Oxide 16.5% … Sunscreen
Medication Information
Warnings and Precautions
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 swallowed, get medical help or contact a Poison Control Center right away.
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
Apply lip serum generously and evenly
Apply liberally 15 minutes before sun exposure
Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months of age: Ask a doctor
Description
Zinc Oxide 16.5% … Sunscreen
Section 50565-1
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 51727-6
Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, C12-15 Alkyl Benzoate, Glycerin, Sorbitan Sesquioleate, Hydrogenated Poly(C6-14 Olefin), Mica, Glyceryl Dibehenate, Flavor, Microcrystalline Cellulose, Tribehenin, Polyglyceryl-3 Diisostearate, Microcrystalline Wax, Cellulose Gum, Synthetic Fluorphlogopite, Glyceryl Behenate, Lecithin, Caprylyl Glycol, Sodium Chloride, Citric Acid, Ethylhexylglycerin, Polyglyceryl-4 Oleate, Sodium Citrate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Limonene, Titanium Dioxide (CI 77891), Red 7 Lake (CI 15850)
Section 51945-4
0.35 FL. OZ. 10g NDC: 83302-165-11
Section 55105-1
Sunscreen
Section 55106-9
Zinc Oxide 16.5% … Sunscreen
Section 59845-8
Apply lip serum generously and evenly
Reapply at least every 2 hours throughout the day as needed
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 your time in the sun, especially from 10 a.m. to 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
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)
Apply lip serum generously and evenly
Apply liberally 15 minutes before sun exposure
Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months of age: Ask a doctor
Warnings and Precautions (34071-1)
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 swallowed, get medical help or contact a Poison Control Center right away.
Section 50565-1 (50565-1)
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 51727-6 (51727-6)
Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, C12-15 Alkyl Benzoate, Glycerin, Sorbitan Sesquioleate, Hydrogenated Poly(C6-14 Olefin), Mica, Glyceryl Dibehenate, Flavor, Microcrystalline Cellulose, Tribehenin, Polyglyceryl-3 Diisostearate, Microcrystalline Wax, Cellulose Gum, Synthetic Fluorphlogopite, Glyceryl Behenate, Lecithin, Caprylyl Glycol, Sodium Chloride, Citric Acid, Ethylhexylglycerin, Polyglyceryl-4 Oleate, Sodium Citrate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Limonene, Titanium Dioxide (CI 77891), Red 7 Lake (CI 15850)
Section 51945-4 (51945-4)
0.35 FL. OZ. 10g NDC: 83302-165-11
Section 55105-1 (55105-1)
Sunscreen
Section 55106-9 (55106-9)
Zinc Oxide 16.5% … Sunscreen
Section 59845-8 (59845-8)
Apply lip serum generously and evenly
Reapply at least every 2 hours throughout the day as needed
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 your time in the sun, especially from 10 a.m. to 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:35.767286 · Updated: 2026-03-14T23:13:32.363247