SPL v1
SPL
SPL Set ID 1eacdde1-f990-4962-92f1-3f41a8a3b193
Route
TOPICAL
Published
Effective Date 2025-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (19.6 g)
Inactive Ingredients
Water C13-15 Alkane Butyloctyl Salicylate Ethylhexyl Olivate Glycerin Zea Mays (corn) Starch Argania Spinosa Kernel Oil Propanediol .alpha.-tocopherol Acetate Polyhydroxystearic Acid (2300 Mw) Inulin Lauryl Carbamate Pentylene Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Phenoxyethanol Sodium Acrylates Crosspolymer-2 Bisabolol Lauroyl Lysine Clove Squalane Solidago Virgaurea Flowering Top Tocopherol Betaine Niacinamide Panthenol Polyglyceryl-2 Dipolyhydroxystearate Polyglyceryl-3 Diisostearate Powdered Cellulose Ethylhexylglycerin 1,2-hexanediol Sorbitan Isostearate Trisodium Ethylenediamine Disuccinate Biosaccharide Gum-4 Silicon Dioxide Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-26

Description

Zinc oxide, 19.6 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc oxide, 19.6 %

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
Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove

Stop use and ask a doctor ifrash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating:
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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

Product Label

Active Ingredient

Zinc oxide, 19.6 %

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

water, C13-15 alkane, butyloctyl salicylate, ethylhexyl olivate, glycerin, zea mays (corn) starch, argania spinosa kernel oil, propanediol, tocopheryl acetate, polyhydroxystearic acid, inulin lauryl carbamate, pentylene glycol, 1,2-hexanediol, betaine, biosaccharide gum-4, bisabolol, cellulose, ethylhexylglycerin, eugenia caryophyllus (clove) bud extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, lauroyl lysine, niacinamide, panthenol, phenoxyethanol, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, silica, sodium acrylates crosspolymer-2, sodium hyaluronate, solidago virgaurea (goldenrod) extract, sorbitan isostearate, squalane, tocopherol, trisodium ethylenediamine disuccinate


Structured Label Content

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
Purpose

Sunscreen

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove

Stop use and ask a doctor ifrash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating:
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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

Product Label (Product label)

Active Ingredient (Active ingredient)

Zinc oxide, 19.6 %

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

water, C13-15 alkane, butyloctyl salicylate, ethylhexyl olivate, glycerin, zea mays (corn) starch, argania spinosa kernel oil, propanediol, tocopheryl acetate, polyhydroxystearic acid, inulin lauryl carbamate, pentylene glycol, 1,2-hexanediol, betaine, biosaccharide gum-4, bisabolol, cellulose, ethylhexylglycerin, eugenia caryophyllus (clove) bud extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, lauroyl lysine, niacinamide, panthenol, phenoxyethanol, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, silica, sodium acrylates crosspolymer-2, sodium hyaluronate, solidago virgaurea (goldenrod) extract, sorbitan isostearate, squalane, tocopherol, trisodium ethylenediamine disuccinate


Advanced Ingredient Data


Raw Label Data

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