Drug Facts
141bb721-cd1c-5bba-e063-6394a90ab8fa
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients Titanium Dioxide 3.7% Zinc Oxide 10.5%
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 • shake well before use • apply generousty15 minutes before sun exposure • children under 6 months of age:Ask a doctor • reapply: • after 80 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 Titanium Dioxide 3.7% Zinc Oxide 10.5%
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, C13-15 Alkane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-3 Polyricinoleate, Squalane, Coco-Caprylate/ Caprate, Disteardimonium Hectorite, Polyglyceryl-10 Dioleate, Polyhydroxystearic Acid, Cetyl Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Acetyl Zingerone, Hydrated Silica, Alumina, Ethylhexylglycerin, Allantoin, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Enteromorpha Compressa Extract, Triethoxycaprysilane, Methyl Propanediol, Ectoin, Camellia Sinensis Leaf Extract, Silybum Marianum Fruit Extract, Ocimum Sanctum Leaf Extract, Caprylyl Glycol, Palmitic Acid, Haematococcus Pluvialis Extract, Sodium Benzoate, Potassium Sorbate, Tetrahexyldecyl Ascorbate, Panthenol, Tocopherol, citric Acid, Phenylpropanol, Magnesium Oxide, CI 77499, CI 77491, CI 77492.
Section 51945-4
Section 55105-1
Purpose :Sunscreen
Section 55106-9
Active ingredients
Titanium Dioxide 3.7%
Zinc Oxide 10.5%
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 • shake well before use • apply generousty15 minutes before sun exposure • children under 6 months of age:Ask a doctor • reapply: • after 80 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, C13-15 Alkane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-3 Polyricinoleate, Squalane, Coco-Caprylate/ Caprate, Disteardimonium Hectorite, Polyglyceryl-10 Dioleate, Polyhydroxystearic Acid, Cetyl Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Acetyl Zingerone, Hydrated Silica, Alumina, Ethylhexylglycerin, Allantoin, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Enteromorpha Compressa Extract, Triethoxycaprysilane, Methyl Propanediol, Ectoin, Camellia Sinensis Leaf Extract, Silybum Marianum Fruit Extract, Ocimum Sanctum Leaf Extract, Caprylyl Glycol, Palmitic Acid, Haematococcus Pluvialis Extract, Sodium Benzoate, Potassium Sorbate, Tetrahexyldecyl Ascorbate, Panthenol, Tocopherol, citric Acid, Phenylpropanol, Magnesium Oxide, CI 77499, CI 77491, CI 77492.
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose :Sunscreen
Section 55106-9 (55106-9)
Active ingredients
Titanium Dioxide 3.7%
Zinc Oxide 10.5%
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: 2026-02-15T12:02:53.890745 · Updated: 2026-03-14T23:02:40.652524