Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 34f674c1-5d59-915a-e063-6394a90a6c2f
Route
TOPICAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17.5 g)
Inactive Ingredients
Hydrolyzed Jojoba Esters Acacia Senegal Gum Sodium Phytate Cetearyl Alcohol Allantoin Polyglyceryl-3 Pentaricinoleate Ci 77491 Isostearic Acid Caesalpinia Spinosa Fruit Pod Hexylene Glycol Xanthan Gum Propylene Glycol Ci 77499 Polyhydroxystearic Acid (2300 Mw) Acai Sorbitan Olivate Methyl Dihydroabietate Caprylyl/capryl Glucoside Sorbitan Palmitate Helianthus Annuus Sprout Caprylyl Glycol Triethoxycaprylylsilane Ci 77492 Caprylic/capric Triglyceride Cetyl Palmitate Lecithin, Sunflower .alpha.-tocopherol Acetate Oryza Sativa (rice) Starch Ethylhexylglycerin Ethyl Ferulate Bisabolol Alumina Phenoxyethanol Magnesium Oxide Coco-glucoside Tetrahexyldecyl Ascorbate Camellia Sinensis Leaf Sodium Benzoate Potassium Sorbate Water Glycerin Sheanut

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12

Description

Active ingredient: Zinc Oxide 17.5 %.


Medication Information

Warnings and Precautions

Warnings

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:

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours

Use a water-resistant sunscreen If swimming or sweating.

Children under 6 months of age: Ask a Doctor.

Sun Probation 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

Active ingredient: 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 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, 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, Triethoxycaprylylsilane, Alumina, Magnesium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4

Section 55105-1

Purpose : Sunscreen

Section 55106-9

Active ingredient: 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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours

Use a water-resistant sunscreen If swimming or sweating.

Children under 6 months of age: Ask a Doctor.

Sun Probation 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

Warnings and Precautions (34071-1)

Warnings

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, 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, Triethoxycaprylylsilane, Alumina, Magnesium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose : Sunscreen

Section 55106-9 (55106-9)

Active ingredient: 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

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