Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 02f9c859-8d7d-5146-e063-6394a90a57b5
Route
TOPICAL
Published
Effective Date 2023-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17.5 g)
Inactive Ingredients
Glycerin Helianthus Annuus Sprout Xanthan Gum Phenoxyethanol Isostearic Acid Tetrahexyldecyl Ascorbate Caprylyl/capryl Oligoglucoside Allantoin Polyhydroxystearic Acid (2300 Mw) Starch, Rice Lecithin, Soybean Medium-chain Triglycerides Cetyl Palmitate Polyglyceryl-3 Pentaricinoleate Phytate Sodium Ethylhexylglycerin Sheanut Levomenol Hydrolyzed Jojoba Esters (potassium Salts) Acacia Hexylene Glycol .alpha.-tocopherol Acetate Water Sorbitan Monopalmitate Methyl Dihydroabietate Cetostearyl Alcohol Sorbitan Olivate Peptide-t Green Tea Leaf Potassium Sorbate Coco Glucoside Ethyl Ferulate Sodium Benzoate Acai Caesalpinia Spinosa Fruit Pod Caprylyl Glycol Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-15
Description

Active ingredients – Zinc Oxide 17.5 %

Medication Information

Warnings and Precautions

Warning – For external use only

Indications and Usage

Uses –

Helps prevent sunburn

If used as directed with other sun protection measures (See direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Direction-

Apply liberally 15 minutes before sun exposure.

Reapply at least every two 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 the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:

Limit time in the sun. especially from 10 am to 2 pm

Wear long-sleeved shirts, pants hats and sunglasses.

Description

Active ingredients – Zinc Oxide 17.5 %

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 doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients:

Water(aqua), Caprylic/Capric Triglyceride, Glycerin, Methyl Dihydroabietate, Cetearyl Alcohol, Cetyl Palmitate, Coco-Glucoside, Caprylyl/Capryl Glucoside, Sorbitan Palmitate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Nut Extract, Ethyl Ferulate, Bisabolol, Allantoin, Hydrolyzed Jojoba Esters, Acacia Senegal Gum, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Decapeptide-52*, Oryza Sativa (rice) Starch,Camellia Sinensis Leaf Extract, Euterpe Oleracea Fruit Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Sodium Phytate, Propylene Glycol, Phenoxyethanol, sodium Benzoate, Potassium Sorbate.

Section 51945-4

Section 55105-1

Purpose – Sunscreen

Section 55106-9

Active ingredients – Zinc Oxide 17.5 %

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 direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Direction-

Apply liberally 15 minutes before sun exposure.

Reapply at least every two 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 the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:

Limit time in the sun. especially from 10 am to 2 pm

Wear long-sleeved shirts, pants hats and sunglasses.

Warnings and Precautions (34071-1)

Warning – 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 doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eye. 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:

Water(aqua), Caprylic/Capric Triglyceride, Glycerin, Methyl Dihydroabietate, Cetearyl Alcohol, Cetyl Palmitate, Coco-Glucoside, Caprylyl/Capryl Glucoside, Sorbitan Palmitate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Nut Extract, Ethyl Ferulate, Bisabolol, Allantoin, Hydrolyzed Jojoba Esters, Acacia Senegal Gum, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Decapeptide-52*, Oryza Sativa (rice) Starch,Camellia Sinensis Leaf Extract, Euterpe Oleracea Fruit Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Sodium Phytate, Propylene Glycol, Phenoxyethanol, sodium Benzoate, Potassium Sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose – Sunscreen

Section 55106-9 (55106-9)

Active ingredients – Zinc Oxide 17.5 %

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: 2026-02-15T12:04:40.815075 · Updated: 2026-03-14T23:05:35.877028