Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 039fba4b-720a-9199-e063-6394a90adbfb
Route
TOPICAL
Published
Effective Date 2023-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (18.6 g)
Inactive Ingredients
Cyclomethicone 5 Glycyrrhizinate Dipotassium Tocopherol Phenoxyethanol Hexylene Glycol Edetate Disodium Anhydrous Cetyl Alcohol Medium-chain Triglycerides Sorbitan Monostearate Lecithin, Soybean Ethylhexylglycerin Ascorbyl Palmitate Peg-100 Stearate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Micrococcus Luteus Polygonum Aviculare Top Sodium Lactate Linoleic Acid Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Xanthan Gum Ascorbic Acid Arabidopsis Thaliana Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Cyclomethicone 6 Glyceryl Monostearate Date Polyethylene Glycol 400 C13-14 Isoparaffin Caprylyl Glycol Imperata Cylindrica Root Citric Acid Monohydrate Carbomer Homopolymer, Unspecified Type Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Water Butylene Glycol Laureth-7 Glycerin Teprenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-23

Description

ACTIVE INGREDIENTS: Zinc Oxide – 18.6 %


Medication Information

Warnings and Precautions

Warning:

For external use only

Indications and Usage

Uses: Helps prevent sunburn. If used as directed with other sun protection measures, this product decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Direction:

Apply liberally 15 minutes before sun exposure.

Children under 6 month of age: Ask a doctor

Reapply at least every 2 hours.

Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases 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 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.

Description

ACTIVE INGREDIENTS: Zinc Oxide – 18.6 %

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 if rash occurs.

Section 50567-7

When using this product keep out of eye. Rinse with water to remove.

Section 50570-1

Do not use on damage or broken skin.

Section 51727-6

INACTIVE INGREDIENT: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Sorbitan Stearate, Cetyl Alcohol, Teprenone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Imperata Cylendrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Lecithin, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/ Oleate, Citric Acid, Polyacrylamide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Xanthan Gum, C13-14 Isoparaffin, Laureth-7, PEG-8, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Asccorbyl Palmitate, Ascorbc Acid, Fragrance, Disodium EDTA.

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

ACTIVE INGREDIENTS:

Zinc Oxide – 18.6 %

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, this product decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Direction:

Apply liberally 15 minutes before sun exposure.

Children under 6 month of age: Ask a doctor

Reapply at least every 2 hours.

Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases 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 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.

Warnings and Precautions (34071-1)

Warning:

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 if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eye. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damage or broken skin.

Section 51727-6 (51727-6)

INACTIVE INGREDIENT: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Sorbitan Stearate, Cetyl Alcohol, Teprenone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Imperata Cylendrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Lecithin, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/ Oleate, Citric Acid, Polyacrylamide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Xanthan Gum, C13-14 Isoparaffin, Laureth-7, PEG-8, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Asccorbyl Palmitate, Ascorbc Acid, Fragrance, Disodium EDTA.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Zinc Oxide – 18.6 %

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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