Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0c574a9a-edea-d333-e063-6394a90a41e3
Route
TOPICAL
Published
Effective Date 2023-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (18.9 g)
Inactive Ingredients
Sorbitan Monostearate Gardenia Jasminoides Fruit Almond Oil Aloe Vera Leaf Lecithin, Soybean Phytate Sodium Isostearic Acid Cetyl Alcohol Niacinamide Totarol Phormium Tenax Seed Oil Carrageenan Cetearyl Glucoside Glycerin Punica Granatum Root Bark Benzyl Alcohol Water Ferulic Acid Tocopherol Honey Stearic Acid Medium-chain Triglycerides Astaxanthin Stearyl Alcohol Xanthan Gum Polysorbate 60 Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-3 Pentaricinoleate Dehydroacetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-12

Description

Active Ingredients: Zinc Oxide 18.9%


Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

Uses • helps to 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 • Use a water-resistant sunscreen if swimming or sweating • Children under 6 months: Ask a doctor • Reapply: • after swimming or sweating • immediately after towel drying • at least every 2 hours • 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10am - 2pm • wear long-sleeve shirts, pants, hats, and sunglasses.

Description

Active Ingredients: Zinc Oxide 18.9%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor • 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:

Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60*, Sorbitan Stearate, Stearic Acid, Cetearyl Glucoside, Cetyl Alcohol, Astaxanthin, Niacinamide (Vitamin B3), Ferulic Acid, Tocopherol (Vitamin E), Totarol (Podocarpus Totara), Mel (Manuka Honey), Phormium Tenax (Harakeke) Seed Oil, Gardenia Jasminoides Meristem Cell Culture, Punica Granatum (Pomegranate) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aloe Barbadensis Leaf Juice, Carrageenan, Lecithin, Xanthan Gum, Sodium Phytate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Dehydroacetic Acid, Stearyl Alcohol, Benzyl Alcohol. *Tween 60-LQ(AP)

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide 18.9%

Section 60561-8

Other information • Protect this product from excessive heat or direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses • helps to 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 • Use a water-resistant sunscreen if swimming or sweating • Children under 6 months: Ask a doctor • Reapply: • after swimming or sweating • immediately after towel drying • at least every 2 hours • 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10am - 2pm • wear long-sleeve 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor • 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:

Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60*, Sorbitan Stearate, Stearic Acid, Cetearyl Glucoside, Cetyl Alcohol, Astaxanthin, Niacinamide (Vitamin B3), Ferulic Acid, Tocopherol (Vitamin E), Totarol (Podocarpus Totara), Mel (Manuka Honey), Phormium Tenax (Harakeke) Seed Oil, Gardenia Jasminoides Meristem Cell Culture, Punica Granatum (Pomegranate) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aloe Barbadensis Leaf Juice, Carrageenan, Lecithin, Xanthan Gum, Sodium Phytate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Dehydroacetic Acid, Stearyl Alcohol, Benzyl Alcohol. *Tween 60-LQ(AP)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide 18.9%

Section 60561-8 (60561-8)

Other information • Protect this product from excessive heat or direct sun.


Advanced Ingredient Data


Raw Label Data

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