Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b63b99af-2ddb-3535-e053-2a95a90a65d5
Route
TOPICAL
Published
Effective Date 2020-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (189 mg)
Inactive Ingredients
Tetrahexyldecyl Ascorbate Tribasic Calcium Phosphate Cannabidiol Caesalpinia Spinosa Fruit Pod Apple Phenoxyethanol Ethylhexylglycerin Cetostearyl Alcohol Aloe Vera Leaf Hydrogenated Jojoba Oil, Randomized Water Xanthan Gum Polyhydroxystearic Acid (2300 Mw) Medium-chain Triglycerides Cetearyl Glucoside Isostearic Acid Sheanut Tocopherol Helianthus Annuus Sprout Propylene Glycol Sodium Benzoate Coconut Alkanes Glycerin Coco Glucoside Glycyrrhizinate Dipotassium Polyglyceryl-3 Pentaricinoleate Phytate Sodium Alcohol Caprylyl/capryl Oligoglucoside Lecithin, Soybean Coco-caprylate/caprate Powdered Cellulose Betasizofiran

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-11
Description

Active Ingredient Zinc Oxide 18.90%

Medication Information

Warnings and Precautions

Warnings:

  • For External Use Only
Indications and Usage

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measure, this product 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.
  • Children under 6 months of age: Ask a doctor
  • Reapply at least every 2 hours.

Description

Active Ingredient Zinc Oxide 18.90%

Section 50565-1

Keep out of reach odf childern. If product is swallowed, get medical help or contact a posion control center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Other Ingredients: Water (Aqua), Caprylic/Capric Triglyceride , Coco-Caprylate/Caprate , Cetearyl Alcohol, Glycerin , Aloe Barbadensis Leaf Juice , Coco-Glucoside, Jojoba Esters , Dipotassium Glycyrrhizate , Sodium Phytate, Alcohol, Caprylyl/Capryl Glucoside, Xanthan Gum , Sclerotium Gum, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Cetearyl Glucoside, Butyrospermum Parkii Nut Extract , Coconut Alkanes , Tocopherol , Tetrahexyldecyl Ascorbate, Cellulose (Microsponge/Delivery System), Hydroxyapatite, Cannabidiol (From Hemp Extract) , Caesalpinia Spinosa Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Pyrus Malus (Apple) Fruit Extract , Sodium Benzoate, Phenoxyethanol , Ethylhexylglycerin, Propylene Glycol

Section 51945-4

Msanufacture for

Dermaquest®, Inc.

Hayward, CA-94544

Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredient

Zinc Oxide 18.90%

Section 60561-8

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 Specturm SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially form 10 a.m. - 2:0 pm
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Protect the product in this container form 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 measure, this product 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.
  • Children under 6 months of age: Ask a doctor
  • Reapply at least every 2 hours.

Warnings and Precautions (34071-1)

Warnings:

  • For External Use Only
Section 50565-1 (50565-1)

Keep out of reach odf childern. If product is swallowed, get medical help or contact a posion control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Other Ingredients: Water (Aqua), Caprylic/Capric Triglyceride , Coco-Caprylate/Caprate , Cetearyl Alcohol, Glycerin , Aloe Barbadensis Leaf Juice , Coco-Glucoside, Jojoba Esters , Dipotassium Glycyrrhizate , Sodium Phytate, Alcohol, Caprylyl/Capryl Glucoside, Xanthan Gum , Sclerotium Gum, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Cetearyl Glucoside, Butyrospermum Parkii Nut Extract , Coconut Alkanes , Tocopherol , Tetrahexyldecyl Ascorbate, Cellulose (Microsponge/Delivery System), Hydroxyapatite, Cannabidiol (From Hemp Extract) , Caesalpinia Spinosa Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Pyrus Malus (Apple) Fruit Extract , Sodium Benzoate, Phenoxyethanol , Ethylhexylglycerin, Propylene Glycol

Section 51945-4 (51945-4)

Msanufacture for

Dermaquest®, Inc.

Hayward, CA-94544

Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 18.90%

Section 60561-8 (60561-8)

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 Specturm SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially form 10 a.m. - 2:0 pm
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Protect the product in this container form excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.376376 · Updated: 2026-03-14T23:05:33.999008