Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 42f3999f-4163-fadc-e063-6294a90aacf3
Route
TOPICAL
Published
Effective Date 2025-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-06
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 Chloride, Maltodextrin, Phenoxyethanol, Xanthan Gum, Polyhydroxystearic acid, Polyglyceryl – 3 Polyricinoleate, Isosteric acid, Lecithin, Caprylyl Glycol, Coco-Caprylate/-Caprate, Ethylhexylglycerin, Hexylene Glycol, Sodium Ascorbyl Phosphate, Caesalpinia Spinosa Fruit Pod Extract, Opuntia Ficus-Indica Stem Extract, Niacinamide, Helianthus Annuus ( Sunflower) Sprout Extract,Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Sodium Benzoate, Citric Acid, Potassium Sorbate, 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 Chloride, Maltodextrin, Phenoxyethanol, Xanthan Gum, Polyhydroxystearic acid, Polyglyceryl – 3 Polyricinoleate, Isosteric acid, Lecithin, Caprylyl Glycol, Coco-Caprylate/-Caprate, Ethylhexylglycerin, Hexylene Glycol, Sodium Ascorbyl Phosphate, Caesalpinia Spinosa Fruit Pod Extract, Opuntia Ficus-Indica Stem Extract, Niacinamide, Helianthus Annuus ( Sunflower) Sprout Extract,Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Sodium Benzoate, Citric Acid, Potassium Sorbate, 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: 2026-02-15T12:08:57.642056 · Updated: 2026-03-14T23:13:28.374847