22c05215-4983-b32e-e063-6394a90a9f67

SPL v2
SPL
SPL Set ID 22c05215-4983-b32e-e063-6394a90a9f67
Route
topical
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (170 mg)
Inactive Ingredients
lauryl polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) echium plantagineum seed oil cardiospermum halicacabum flowering top hyaluronate sodium water butyloctyl salicylate polymethylsilsesquioxane (4.5 microns) caprylyl glycol octyldodecanol ethylhexylglycerin tocopherol sunflower oil unsaponifiables panthenol methyl methacrylate/glycol dimethacrylate crosspolymer triethoxycaprylylsilane polyglyceryl-2 dipolyhydroxystearate propanediol propylheptyl caprylate caprylyl trisiloxane polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) magnesium sulfate, unspecified 1,2-hexanediol isododecane citric acid monohydrate glyceryl caprylate disteardimonium hectorite

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-01

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

Purpose

Zinc Oxide 17% ....... Sunscreen

Description

Zinc Oxide 17% ....... Sunscreen


Medication Information

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Indications and Usage

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Zinc Oxide 17% ....... Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • 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 Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Dosage and Administration

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Water, Propylheptyl Caprylate, Butyloctyl Salicylate, Propanediol, Caprylyl Methicone, Isododecane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Magnesium Sulfate, Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glyceryl Caprylate, Caprylyl Glycol, Octyldodecanol, Ethylhexylglycerin, Echium Plantagineum Seed Oil, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hyaluronate, Panthenol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid

Description

Zinc Oxide 17% ....... Sunscreen

Section 51945-4

Active Ingredient...purpose

Zinc Oxide 17% ....... Sunscreen

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Warnings (WARNINGS)

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Indications and Usage (34067-9)

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • 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 Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Dosage and Administration

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

Water, Propylheptyl Caprylate, Butyloctyl Salicylate, Propanediol, Caprylyl Methicone, Isododecane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Magnesium Sulfate, Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glyceryl Caprylate, Caprylyl Glycol, Octyldodecanol, Ethylhexylglycerin, Echium Plantagineum Seed Oil, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hyaluronate, Panthenol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid

Section 51945-4 (51945-4)

Active Ingredient...purpose (Active Ingredient...Purpose)

Zinc Oxide 17% ....... Sunscreen

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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