Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4a6294e3-d755-4439-adc2-fdd45a57cb7d
Route
TOPICAL
Published
Effective Date 2010-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (190 mg)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-01-01
Description

Active Ingredients: Zinc Oxide

Medication Information

Warnings and Precautions

Warnings:

For external use only

When using this product

  • Keep out of eyes. If contact occurs rinse with water.
  • Discontinue use if irritation or redness occurs

Keep out of reach of children

Indications and Usage

Uses:

  • An organic UVA/UVB broad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposures. Enriched with essential vitamins and anti-oxidants that prevent free radical damage and preserving skin hydration for the entire day.
  • Water Resistant
  • Paraben Free
  • Chemical free
Directions:



Apply liberally 15-30minute prior to sun exposure. Reapply after prolonged swimming or vigorous activity.



Indications:



Sensitive skin highly exposed to sun

Description

Active Ingredients: Zinc Oxide

Section 51727-6

Inactive Ingredients:

Water (Aqua), Cyclomethicone, Glycrin, Glyceryl Stearate (and) PEG 100 Stearate, Sorbitol, Imperata Cylindrica Root Extract, Polyacrylamide and C13-14 Isoparaffin and Laureth-7, Caprylyl Glycol and Phenoxyethanol and Hexylene Glycol, Lecithin, Ascorbyl Palmitate (Vitramin C), Xanthan Gum, Dipotassium Glyrhhizate, Olea Europea (Olive) Leaf Extract, Disodium EDTA.

Section 51945-4

Distributor:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com



Image of the product:





Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • An organic UVA/UVB broad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposures. Enriched with essential vitamins and anti-oxidants that prevent free radical damage and preserving skin hydration for the entire day.
  • Water Resistant
  • Paraben Free
  • Chemical free
Directions:



Apply liberally 15-30minute prior to sun exposure. Reapply after prolonged swimming or vigorous activity.



Indications:



Sensitive skin highly exposed to sun

Warnings and Precautions (34071-1)

Warnings:

For external use only

When using this product

  • Keep out of eyes. If contact occurs rinse with water.
  • Discontinue use if irritation or redness occurs

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients:

Water (Aqua), Cyclomethicone, Glycrin, Glyceryl Stearate (and) PEG 100 Stearate, Sorbitol, Imperata Cylindrica Root Extract, Polyacrylamide and C13-14 Isoparaffin and Laureth-7, Caprylyl Glycol and Phenoxyethanol and Hexylene Glycol, Lecithin, Ascorbyl Palmitate (Vitramin C), Xanthan Gum, Dipotassium Glyrhhizate, Olea Europea (Olive) Leaf Extract, Disodium EDTA.

Section 51945-4 (51945-4)

Distributor:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com



Image of the product:





Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:05.135158 · Updated: 2026-03-14T22:52:24.761203