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

Active Ingredient

Active Ingredient: Zinc oxide - 18.6%

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings: For external use only

Active Ingredient (55106-9)

Active Ingredient: Zinc oxide - 18.6%

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.
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

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