Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 25bdc052-9c57-4bcd-a504-1b0434619003
Route
TOPICAL
Published
Effective Date 2010-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (186 mg)

Identifiers & Packaging

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

Active Ingredients: Zinc Oxide 18.6%

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 childrean



Indications and Usage

Uses:

  • An oil-free UVA/UVB brad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposures. Enriched with essential vitamins and ant-oxidants that prevent free radical damage and preserving skin hydration for the entire day.
  • Water-resistant
  • Paraben-free
Direction:



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



Indications:



Universal for all skin types

Description

Active Ingredients: Zinc Oxide 18.6%

Section 51727-6

Inactive Ingredients:

Water (Aqua), Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG 100 Stearate, Sorbitan Stearate, Citric Acid, Imperata Cylidrica Root Extract, Tocopheryl Linoleate, Lecithin, Xanthan Gum, PEG 8, Ascorbic Acid, Ethylhexylglycerin, Sodium Lactate, Micrococcus Lysate, Arabidopsis Extract, Plankton Extract, Teprenone, Phoenix dactylifera (date) extract, Laureth-7, Disodium EDTA, Dipotassium Glycyrrhizte, Caprylyl Glycol, Tocopherol, Ascorbyl Palmitate, Carbomer



Section 51945-4

Distributor:

Image International

Palm Beach, FL 33411 USA



Image of the product:

SUN Solar Defense Oil-free Gel SPF 30



Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide 18.6%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • An oil-free UVA/UVB brad spectrum daily moisturizer. Provides ultimate protection against the aging effects of the sun and other environmental exposures. Enriched with essential vitamins and ant-oxidants that prevent free radical damage and preserving skin hydration for the entire day.
  • Water-resistant
  • Paraben-free
Direction:



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



Indications:



Universal for all skin types

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 childrean



Section 51727-6 (51727-6)

Inactive Ingredients:

Water (Aqua), Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG 100 Stearate, Sorbitan Stearate, Citric Acid, Imperata Cylidrica Root Extract, Tocopheryl Linoleate, Lecithin, Xanthan Gum, PEG 8, Ascorbic Acid, Ethylhexylglycerin, Sodium Lactate, Micrococcus Lysate, Arabidopsis Extract, Plankton Extract, Teprenone, Phoenix dactylifera (date) extract, Laureth-7, Disodium EDTA, Dipotassium Glycyrrhizte, Caprylyl Glycol, Tocopherol, Ascorbyl Palmitate, Carbomer



Section 51945-4 (51945-4)

Distributor:

Image International

Palm Beach, FL 33411 USA



Image of the product:

SUN Solar Defense Oil-free Gel SPF 30



Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide 18.6%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:05.165576 · Updated: 2026-03-14T22:52:24.761203