Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b6b45dac-41d0-1b55-e053-2a95a90acf61
Route
TOPICAL
Published
Effective Date 2020-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (186 mg)
Inactive Ingredients
Butylene Glycol Cyclomethicone 5 Glyceryl Monostearate Sorbitan Monostearate Caprylyl Glycol Imperata Cylindrica Root C13-14 Isoparaffin Ethylhexylglycerin Hexylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Butyl Cyanoacetate Helianthus Annuus Sprout Sodium Benzoate Ascorbic Acid 1,2-hexanediol Phenoxyethanol Water Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Medium-chain Triglycerides Glycerin Peg-100 Stearate Polyacrylamide (10000 Mw) Laureth-7 Glycyrrhizinate Dipotassium Micrococcus Luteus Tocopherol Dimethicone Polyethylene Glycol 400 Cetyl Alcohol Citric Acid Monohydrate Xanthan Gum .alpha.-tocopherol Linoleate, D- Polygonum Aviculare Top Cyclomethicone 6 Rosa Damascena Flower Sodium Lactate Date Ascorbyl Palmitate Teprenone Edetate Disodium Anhydrous Arabidopsis Thaliana Potassium Sorbate Caesalpinia Spinosa Fruit Pod Tetrahexyldecyl Ascorbate Carboxypolymethylene Lecithin, Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-17
Description

Active Ingredients Zinc Oxide 18.6%

Medication Information

Warnings and Precautions

Warnigs:

  • 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 aging caused by sun.
Dosage and Administration

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a Doctor
  • Reapply at least every 2 hours.
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 eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive Ingredients: Water (Aqua), Cyclopentasiloxane , Butylene Glycol, Glycerin , Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone , Cyclohexasiloxane , Dimethicone , Sorbitan Stearate , Caprylic/Capric Triglyceride, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol , Lecithin , Tocopherol , Ascorbyl Palmitate, Ascorbic Acid, Citric Acid , Xanthan Gum, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract , Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract , Micrococcus Lysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer , Tetrahexyldecyl Ascorbate , Bis(Cyano Butylacetate) Anthracenediylidene, Propylene Glycol , Caesalpinia spinosa Fruit Pod Extract , Helianthus Annuus(Sunflower) Sprout Extract, Sodium Benzoate , Potassium Sorbate, Rosa Damascena Flower Extract , 1,2-Hexanediol

Section 51945-4

Manufacture for Dermaquest®, Inc.

Hayward, CA 94544

1272 GL, NL Made in USA

dermaquestinc.com

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 aging caused by sun.
Dosage and Administration (34068-7)

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a Doctor
  • Reapply at least every 2 hours.
Warnings and Precautions (34071-1)

Warnigs:

  • 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 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), Cyclopentasiloxane , Butylene Glycol, Glycerin , Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone , Cyclohexasiloxane , Dimethicone , Sorbitan Stearate , Caprylic/Capric Triglyceride, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol , Lecithin , Tocopherol , Ascorbyl Palmitate, Ascorbic Acid, Citric Acid , Xanthan Gum, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract , Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract , Micrococcus Lysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer , Tetrahexyldecyl Ascorbate , Bis(Cyano Butylacetate) Anthracenediylidene, Propylene Glycol , Caesalpinia spinosa Fruit Pod Extract , Helianthus Annuus(Sunflower) Sprout Extract, Sodium Benzoate , Potassium Sorbate, Rosa Damascena Flower Extract , 1,2-Hexanediol

Section 51945-4 (51945-4)

Manufacture for Dermaquest®, Inc.

Hayward, CA 94544

1272 GL, NL Made in USA

dermaquestinc.com

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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:41.279445 · Updated: 2026-03-14T23:05:35.877028