Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1b582f4e-553f-a511-e063-6294a90af3c0
Route
TOPICAL
Published
Effective Date 2024-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14 g)
Inactive Ingredients
Bifidobacterium Animalis Lactis Candelilla Wax Carbomer Homopolymer, Unspecified Type Sheanut Phytosphingosine Sodium Benzoate Phenoxyethanol Caesalpinia Spinosa Fruit Pod Safflower Oil Medium-chain Triglycerides Polyglyceryl-3 Pentaricinoleate Butyloctyl Salicylate Helianthus Annuus Seed Wax Sodium Lauroyl Lactylate Helianthus Annuus Sprout Isostearic Acid Lecithin, Soybean Stearalkonium Hectorite Quaternium-90 Bentonite Camellia Oil Aloe Vera Leaf Malpighia Emarginata Seed Ceramide Np Ceramide Ap Polyhydroxystearic Acid (2300 Mw) Cholesterol Xanthan Gum Citric Acid Monohydrate Triethyl Citrate C13-15 Alkane Coconut Alkanes Coco-caprylate/caprate Hexylene Glycol Propylene Glycol Propylene Carbonate Ethylhexylglycerin Caprylyl Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-20
Description

Active ingredients – Zinc Oxide 14 %

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 after 80 minutes of swimming or sweating.

immediately after towel drying, at least every 2 hours

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 14 %

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: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.

Section 51945-4

Section 55105-1

Purpose – Sunscreen

Section 55106-9

Active ingredients – Zinc Oxide 14 %

Section 60561-8

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 after 80 minutes of swimming or sweating.

immediately after towel drying, at least every 2 hours

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: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose – Sunscreen

Section 55106-9 (55106-9)

Active ingredients – Zinc Oxide 14 %

Section 60561-8 (60561-8)

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: 2026-02-15T12:03:11.056761 · Updated: 2026-03-14T23:03:07.791514