SPL v1
SPL
SPL Set ID 30d49f24-3e13-385f-e063-6294a90ab5c8
Route
TOPICAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (18.24 g)
Inactive Ingredients
Tara Spinosa Fruit Houttuynia Cordata Flowering Top Water Caprylyl Glycol Trisiloxane Caprylyl Methicone Lauroyl Lysine Buddleja Officinalis Flower Glyceryl Caprylate Dipropylene Glycol Hydroxypropyl Betadex Sodium Citrate Butylene Glycol Magnesium Sulfate Isododecane Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Sodium Chloride 1,2-hexanediol Polyglyceryl-2 Dipolyhydroxystearate Kappaphycus Alvarezii Tocopherol Glycerin Palmitoyl Tripeptide-5 Coco-caprylate/caprate Triethylhexanoin Panthenol Ceramide Np Maritime Pine Propylheptyl Caprylate Neopentyl Glycol Diheptanoate Disteardimonium Hectorite Centella Asiatica Triterpenoids 7-dehydrocholesterol Butyloctyl Salicylate Triethoxycaprylylsilane Propanediol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Zinc Oxide 18.24%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18.24%

Use
  • 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 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.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: Ask a doctor.
  • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 am .- 2 p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Package Label

Active Ingredient

Zinc Oxide 18.24%

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

Water(Aqua/Eau), Butyloctyl Salicylate, Trisiloxane, Propylheptyl Caprylate, Butylene Glycol, Propanediol, Isododecane, Coco-Caprylate/Caprate, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Neopentyl Glycol Diheptanoate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Triethoxycaprylylsilane, Triethylhexanoin, 1,2-Hexanediol, Cetyl Dimethicone, Disteardimonium Hectorite, Lauroyl Lysine, Polyglyceryl-2 Dipolyhydroxystearate, Magnesium Sulfate, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Caprylyl Glycol, Glyceryl Caprylate, Tocopherol, Dipropylene Glycol, Panthenol, Sodium Citrate, Glycerin, Ceramide NP, Hydrolyzed Hyaluronic Acid, Caesalpinia Spinosa Fruit Extract, Bacillus Ferment, Kappaphycus Alvarezii Extract, Hydroxypropyl Cyclodextrin, Buddleja Officinalis Flower Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Palmitoyl Tripeptide-5, 7-Dehydrocholesterol, Pinus Pinaster Bark Extract

Questions Or Comments?

Contact to www.dr-g.com

Keep Out of Reach of Children.

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


Structured Label Content

Use
  • 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 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.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: Ask a doctor.
  • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 am .- 2 p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Package Label (PACKAGE LABEL)

Active Ingredient (Active ingredient)

Zinc Oxide 18.24%

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

Water(Aqua/Eau), Butyloctyl Salicylate, Trisiloxane, Propylheptyl Caprylate, Butylene Glycol, Propanediol, Isododecane, Coco-Caprylate/Caprate, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Neopentyl Glycol Diheptanoate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Triethoxycaprylylsilane, Triethylhexanoin, 1,2-Hexanediol, Cetyl Dimethicone, Disteardimonium Hectorite, Lauroyl Lysine, Polyglyceryl-2 Dipolyhydroxystearate, Magnesium Sulfate, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Caprylyl Glycol, Glyceryl Caprylate, Tocopherol, Dipropylene Glycol, Panthenol, Sodium Citrate, Glycerin, Ceramide NP, Hydrolyzed Hyaluronic Acid, Caesalpinia Spinosa Fruit Extract, Bacillus Ferment, Kappaphycus Alvarezii Extract, Hydroxypropyl Cyclodextrin, Buddleja Officinalis Flower Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Palmitoyl Tripeptide-5, 7-Dehydrocholesterol, Pinus Pinaster Bark Extract

Questions Or Comments? (Questions or comments?)

Contact to www.dr-g.com

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

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


Advanced Ingredient Data


Raw Label Data

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