Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 16268c31-2151-20e0-e063-6294a90a7965
Route
TOPICAL
Published
Effective Date 2024-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (21 g)
Inactive Ingredients
Honey Phytate Sodium Xanthan Gum Isostearic Acid Sunflower Oil Squalene .beta.-sitosterol Caprylhydroxamic Acid Starch, Rice Polyglyceryl-3 Pentaricinoleate Spirulina Maxima Phaeodactylum Tricornutum Decyl Alcohol Coco Glucoside Cetearyl Glucoside Aloe Vera Leaf Argan Oil Oatmeal Shea Butter Cetostearyl Alcohol Coconut Alkanes Betasizofiran Anhydrous Dextrose Water Medium-chain Triglycerides Tocopherol Sucrose Levomenol Caprylyl/capryl Oligoglucoside Glycyrrhizinate Dipotassium Glycerin .alpha.-tocopherol Acetate Glyceryl Caprylate Coco-caprylate/caprate Lecithin, Soybean Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-15

Description

Active ingredient Zinc Oxide 21%


Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

Use • 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 • children under 6 months: Ask a doctor • 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 sun-glasses.

Description

Active ingredient Zinc Oxide 21%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or call 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, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Glyceryl Caprylate, Coco-Glucoside, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Honey, Avena sativa (Oat) Kernel Flour, Sodium Phytate, Caprylyl/Capryl Glucoside, Xanthan Gum, Dipotassium Glycyrrhizate, Sclerotium Gum, Cetearyl Glucoside, Butyrospermum Parkii (Shea) Butter, Tocopherol, Coco-Caprylate/Caprate, Caprylhydroxamic acid, Sucrose, Spirulina Maxima Extract, Phaeodactylum Tricornutum Extract, Oryza Sativa Starch, Bisabolol,Lecithin, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Beta-Sitosterol, Squalene, Glucose, C8 Alcohol, C10 Alcohol

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active ingredient

Zinc Oxide 21%

Section 60561-8

Other information protect this product from excessive heat and direct sun.

CAUTION:

IF YOU HAVE A KNOWN ALLERGY OR EXPERIENCE SENSITIVITY TO ANY OF THE LIST INGREDIENTS, DISCONTINUE USE. FOR EXTERNAL USE ONLY, DO NOT APPLY TO OPEN WOUNDS.


Structured Label Content

Indications and Usage (34067-9)

Use • 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 • children under 6 months: Ask a doctor • 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 sun-glasses.

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 call 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, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Glyceryl Caprylate, Coco-Glucoside, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Honey, Avena sativa (Oat) Kernel Flour, Sodium Phytate, Caprylyl/Capryl Glucoside, Xanthan Gum, Dipotassium Glycyrrhizate, Sclerotium Gum, Cetearyl Glucoside, Butyrospermum Parkii (Shea) Butter, Tocopherol, Coco-Caprylate/Caprate, Caprylhydroxamic acid, Sucrose, Spirulina Maxima Extract, Phaeodactylum Tricornutum Extract, Oryza Sativa Starch, Bisabolol,Lecithin, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Beta-Sitosterol, Squalene, Glucose, C8 Alcohol, C10 Alcohol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Zinc Oxide 21%

Section 60561-8 (60561-8)

Other information protect this product from excessive heat and direct sun.

CAUTION:

IF YOU HAVE A KNOWN ALLERGY OR EXPERIENCE SENSITIVITY TO ANY OF THE LIST INGREDIENTS, DISCONTINUE USE. FOR EXTERNAL USE ONLY, DO NOT APPLY TO OPEN WOUNDS.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)