Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 2e20c132-8a03-1d5d-e063-6394a90ad2c3
Route
TOPICAL
Published
Effective Date 2026-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (16.1 g)
Inactive Ingredients
Caesalpinia Spinosa Fruit Pod Helianthus Annuus Sprout Coconut Alkanes Polyglyceryl-3 Pentaricinoleate Lecithin, Sunflower Ceramide Ap Hexylene Glycol Carbomer Sodium Benzoate Green Tea Leaf Caprylyl Glycol Cholesterol Sodium Chloride Isopropyl Isostearate Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Opuntia Ficus-indica Stem Ci 77491 Xanthan Gum Ci 77492 Sodium Lauroyl Lactylate Potassium Sorbate Citric Acid Water Glycerin Sodium Ascorbyl Phosphate Ceramide Np Phenoxyethanol Niacinamide Sodium Hyaluronate Ci 77499 Phytosphingosine Polyhydroxystearic Acid (2300 Mw) Isostearic Acid Caprylic/capric Triglyceride C13-15 Alkane Coco-caprylate/caprate Ethylhexylglycerin Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-14
Description

Active ingredients: Zinc Oxide 16.1%

Medication Information

Warnings and Precautions

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 generously 15 minutes before sun exposure ■ Reapply at least every 2 hours ■ Use a water-resistant sunscreen if swimming or sweating ■ Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use 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 ■ Children under 6 months of age: Ask a doctor.

Description

Active ingredients: Zinc Oxide 16.1%

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:

Water(Aqua),Caprylic/capric Triglyceride, Isopropyl Isostearate, Polyglyceryl -4 Diisostearate/Polyhydroxy stearate/sebacate, Coconut Alkanes, C13-15 Alkane, Glycerin, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Chloride, Niacinamide, Sodium Hyaluronate, Camellia Sinensis (Green Tea) Leaf Extract, Opuntia Ficus-Indica Stem (Prickly Pear)Extract, Caesalpinia Spinosa (Spiny Holdback) Fruit Pod Extract, Helianthus Annuus ( Sunflower) Sprout Extract, Coco-Caprylate/-Caprate, Polyhydroxystearic acid, Polyglyceryl – 3 Polyricinoleate, Isosteric acid, Lecithin, Ceramide NP, Ceramide AP, Ceramide EOP, Xanthan Gum, Maltodextrin, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Citric Acid, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate, Carbomer. May Contain +/_ Iron oxides ( CI77491, CI77492, CI 77499)

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active ingredients: Zinc Oxide 16.1%

Section 60561-8

Protect the product in this container from excessive heat and direct sun. May stain some fabrics.

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 generously 15 minutes before sun exposure ■ Reapply at least every 2 hours ■ Use a water-resistant sunscreen if swimming or sweating ■ Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use 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 ■ Children under 6 months of age: Ask a doctor.

Warnings and Precautions (34071-1)

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:

Water(Aqua),Caprylic/capric Triglyceride, Isopropyl Isostearate, Polyglyceryl -4 Diisostearate/Polyhydroxy stearate/sebacate, Coconut Alkanes, C13-15 Alkane, Glycerin, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Chloride, Niacinamide, Sodium Hyaluronate, Camellia Sinensis (Green Tea) Leaf Extract, Opuntia Ficus-Indica Stem (Prickly Pear)Extract, Caesalpinia Spinosa (Spiny Holdback) Fruit Pod Extract, Helianthus Annuus ( Sunflower) Sprout Extract, Coco-Caprylate/-Caprate, Polyhydroxystearic acid, Polyglyceryl – 3 Polyricinoleate, Isosteric acid, Lecithin, Ceramide NP, Ceramide AP, Ceramide EOP, Xanthan Gum, Maltodextrin, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Citric Acid, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate, Carbomer. May Contain +/_ Iron oxides ( CI77491, CI77492, CI 77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active ingredients: Zinc Oxide 16.1%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun. May stain some fabrics.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:34.256275 · Updated: 2026-03-14T23:13:55.868201