Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 34f51ff4-541d-2b2e-e063-6394a90a39da
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
Sorbitan Palmitate Sodium Phytate Bisabolol Cetyl Palmitate Coco Glucoside Camellia Sinensis Leaf Xanthan Gum Cetearyl Alcohol Methyl Dihydroabietate Caprylyl/capryl Glucoside Acacia Senegal Gum Polyglyceryl-3 Pentaricinoleate Ci 77499 Water Caprylyl Glycol Magnesium Oxide Ci 77491 .alpha.-tocopherol Acetate Helianthus Annuus Sprout Triethoxycaprylylsilane Hexylene Glycol Ethyl Ferulate Lecithin, Sunflower Oryza Sativa (rice) Starch Phenoxyethanol Ci 77492 Sorbitan Olivate Sheanut Caesalpinia Spinosa Fruit Pod Ethylhexylglycerin Caprylic/capric Triglyceride Glycerin Allantoin Hydrolyzed Jojoba Esters Polyhydroxystearic Acid (2300 Mw) Isostearic Acid Propylene Glycol Sodium Benzoate Potassium Sorbate Tetrahexyldecyl Ascorbate Acai Alumina

Identifiers & Packaging

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

Description

Active ingredients : 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 ingredients : 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 ingredients : 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 ingredients : 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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