2c749a52-adaa-2609-e063-6294a90a8fc2

SPL v2
SPL
SPL Set ID 2c749a52-adaa-2609-e063-6294a90a8fc2
Route
topical
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (15.45 g)
Inactive Ingredients
butyloctyl salicylate triheptanoin castor oil/ipdi copolymer citric acid calendula officinalis flower dilinoleic acid/butanediol copolymer propylene carbonate calcium gluconate isododecane polyhydroxystearic acid (2300 mw) stearoyl glutamic acid hydroxyacetophenone octyldodecanol lingonberry caprylic/capric triglyceride butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) bisabolol rosemary c12-15 alkyl benzoate glycerin dipotassium glycyrrhizate propanediol cannabis sativa seed oil gluconolactone helianthus annuus flowering top water xanthan gum tocopherol coco-caprylate/caprate polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate oryza sativa (rice) bran c9-12 alkane potassium sorbate sodium chloride stearalkonium hectorite sodium benzoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2022-10-04
Description

Zinc Oxide 15.45%

Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Zinc Oxide 15.45%

Indications and Usage

Helps prevent sunburn

if used as directed with other sun protection measures (see ​directions)​, decreases the risk of skin cancer and early signs of aging caused by the sun.

Dosage and Administration

Directions

For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or sweating.

■ Reapply at least every 2 hours.

■ Not for use on children.

■ 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

Zinc Oxide 15.45%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Centre 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

Water/Aqua/Eau, Isododecane, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Acrylates Copolymer, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Propanediol, Cannabis Sativa Seed Oil, Sodium Chloride, Polyhydroxystearic Acid, Triheptanoin, Stearalkonium Hectorite, Calendula Officinalis Flower Extract, Stearoyl Glutamic Acid, Hydroxyacetophenone, Xanthan Gum, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Propylene Carbonate, Sodium Benzoate, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea Fruit Extract, Potassium Sorbate, Bisabolol, Oryza Sativa (Rice) Bran Extract, Castor Oil/IPDI Copolymer, Octyldodecanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Citric Acid, Gluconolactone, Helianthus Annuus (Sunflower) Extract, Tocopherol, Calcium Gluconate.

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Sunscreen

Section 60561-8

Protect the product in this container from excessive heat and direct sun

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Zinc Oxide 15.45%

Indications and Usage (34067-9)

Helps prevent sunburn

if used as directed with other sun protection measures (see ​directions)​, decreases the risk of skin cancer and early signs of aging caused by the sun.

Dosage and Administration (34068-7)

Directions

For Sunscreen Use:

■ Apply liberally 15 minutes before sun exposure.

■ Use a water resistant sunscreen if swimming or sweating.

■ Reapply at least every 2 hours.

■ Not for use on children.

■ 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.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Centre 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)

Water/Aqua/Eau, Isododecane, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Acrylates Copolymer, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Propanediol, Cannabis Sativa Seed Oil, Sodium Chloride, Polyhydroxystearic Acid, Triheptanoin, Stearalkonium Hectorite, Calendula Officinalis Flower Extract, Stearoyl Glutamic Acid, Hydroxyacetophenone, Xanthan Gum, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Propylene Carbonate, Sodium Benzoate, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea Fruit Extract, Potassium Sorbate, Bisabolol, Oryza Sativa (Rice) Bran Extract, Castor Oil/IPDI Copolymer, Octyldodecanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Citric Acid, Gluconolactone, Helianthus Annuus (Sunflower) Extract, Tocopherol, Calcium Gluconate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-823-7837

Section 55105-1 (55105-1)

Sunscreen

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: 2026-02-15T12:08:51.091910 · Updated: 2026-03-14T23:13:16.476899