Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 526e3b68-4b2d-4fbf-8d7c-de4e59e1ca58
Route
TOPICAL
Published
Effective Date 2017-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (186 mg)
Inactive Ingredients
Water Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Butylene Glycol Glycerin Medium-chain Triglycerides Glyceryl Stearate Se Peg-100 Stearate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Cyclomethicone 6 Sorbitan Monostearate Dimethicone C13-14 Isoparaffin Laureth-7 Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Imperata Cylindrica Root Polyethylene Glycol 400 Carbomer 1342 Cetyl Alcohol Lecithin, Soybean Tocopherol Ascorbyl Palmitate Ascorbic Acid Citric Acid Monohydrate Xanthan Gum Polyester-7 Neopentyl Glycol Diheptanoate .alpha.-tocopherol Linoleate, D- Teprenone Date Polygonum Aviculare Top Sodium Lactate Edetate Disodium Anhydrous Glycyrrhizinate Dipotassium Arabidopsis Thaliana Micrococcus Luteus Triethoxycaprylylsilane Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-11-28
Description

Active Ingredient: Zinc oxide - 18.6%

Medication Information

Warnings and Precautions

Warnings: For external use only

Indications and Usage

Uses:

  • To help protect the skin from harmful UVA and UVB rays
Dosage and Administration

Directions:

  • Apply sunscreen in the AM to finger tips and gently massage into the skin. Reapply as needed.
Description

Active Ingredient: Zinc oxide - 18.6%

Section 50565-1

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Cpntrol center right away.
Section 50566-9

Stop use and ask a doctor

  • If severe skin irritation developes
Section 50567-7

When using this product:

  • Keep out of eyes. If contact occurs, rinse with water.
  • Discontinue use if irritation or redness occurs.
Section 51727-6

Other Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, 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, Polyester-7, Neopentyl Glycol Diheptanoate, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499) 

Section 51945-4

Manufactured for DermaQuest, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredient: Zinc oxide - 18.6%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • To help protect the skin from harmful UVA and UVB rays
Dosage and Administration (34068-7)

Directions:

  • Apply sunscreen in the AM to finger tips and gently massage into the skin. Reapply as needed.
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 Cpntrol center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor

  • If severe skin irritation developes
Section 50567-7 (50567-7)

When using this product:

  • Keep out of eyes. If contact occurs, rinse with water.
  • Discontinue use if irritation or redness occurs.
Section 51727-6 (51727-6)

Other Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, 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, Polyester-7, Neopentyl Glycol Diheptanoate, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499) 

Section 51945-4 (51945-4)

Manufactured for DermaQuest, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredient: Zinc oxide - 18.6%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.238191 · Updated: 2026-03-14T22:54:56.160161