Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 291bbf47-e702-4776-8ed8-3f16232f6506
Route
TOPICAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (189 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Coconut Alkanes Cetostearyl Alcohol Glycerin Aloe Vera Leaf Coco Glucoside Cetearyl Glucoside Caprylyl/capryl Oligoglucoside Apple Green Tea Leaf Sheanut Hydrolyzed Jojoba Esters (acid Form) Coco-caprylate/caprate Glycyrrhizinate Dipotassium Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-3 Ricinoleate Isostearic Acid Lecithin, Soybean Hexasodium Phytate Ethylhexylglycerin Xanthan Gum Tocopherol Betasizofiran Phenoxyethanol Sodium Benzoate Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-24
Description

Active Ingredients: Zinc Oxide 18.9%

Medication Information

Indications and Usage

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Direction), this product decreases the risk of skin cancer and  early skin aging caused by the sun.
Dosage and Administration

Directions:

  • Apply generously 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor. 
  • Reapply at least every 2 hours.
  • Sun protection measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease 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 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Description

Active Ingredients: Zinc Oxide 18.9%

Section 43685-7

Warning: For external use only.

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), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Cetearyl Glucoside, Caprylyl/Capryl Glucoside, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Sodium Phytate, Lecithin, Tocopherol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Ethylhexylglycerin,  Sodium Benzoate, Potassium Sorbate.

Section 51945-4

Manufactured by Allure Labs

For Eczema Honey CO IN

Partnership:

Hayward, CA, 94545

Section 53413-1

Questions or Comments?

Call toll free 707-230-2284; www.eczemahoneyco.com

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide 18.9%

Section 60561-8

Other Information: Protect the product 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 (see Direction), this product decreases the risk of skin cancer and  early skin aging caused by the sun.
Dosage and Administration (34068-7)

Directions:

  • Apply generously 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor. 
  • Reapply at least every 2 hours.
  • Sun protection measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease 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 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Section 43685-7 (43685-7)

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 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), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Cetearyl Glucoside, Caprylyl/Capryl Glucoside, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Sodium Phytate, Lecithin, Tocopherol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Ethylhexylglycerin,  Sodium Benzoate, Potassium Sorbate.

Section 51945-4 (51945-4)

Manufactured by Allure Labs

For Eczema Honey CO IN

Partnership:

Hayward, CA, 94545

Section 53413-1 (53413-1)

Questions or Comments?

Call toll free 707-230-2284; www.eczemahoneyco.com

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide 18.9%

Section 60561-8 (60561-8)

Other Information: Protect the product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:37.092311 · Updated: 2026-03-14T22:58:16.152732