SPL v1
SPL
SPL Set ID 30d53b8a-7e35-0b2b-e063-6294a90aa8df
Route
TOPICAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (6.8 g) Octisalate (4.5 g) Avobenzone (2.85 g)
Inactive Ingredients
Xanthan Gum Sodium Stearoyl Glutamate Leuconostoc/radish Root Ferment Filtrate Maritime Pine Centella Asiatica Triterpenoids Butyloctyl Salicylate Ammonium Acryloyldimethyltaurate/vp Copolymer 1,2-hexanediol Butylene Glycol Dicaprylate/dicaprate Edetate Disodium Tara Spinosa Fruit Asiaticoside Asiatic Acid Buddleja Officinalis Flower Madecassic Acid Propanediol Hydroxyacetophenone Centella Asiatica Leaf Madecassoside Water Polyamide-8 (4500 Mw) Azelaic Acid Ethylhexylglycerin Butylene Glycol Cetyl Alcohol Hydroxypropyl Methylcellulose Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Kappaphycus Alvarezii Benzotriazolyl Dodecyl P-cresol Zea Mays (corn) Starch Polyacrylate Crosspolymer-6 Pentylene Glycol Tromethamine Panthenol Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Xylitol Zinc Pca

Identifiers & Packaging

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

Description

Avobenzone 2.85%, Homosalate 6.8%, Octisalate 4.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.85%, Homosalate 6.8%, Octisalate 4.5%

Use
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and earty skin aging caused by the sun.
Warnings

For externall 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, especiall from 10 am-2 p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Package Label

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

Avobenzone 2.85%,

Homosalate 6.8%, Octisalate 4.5%

Inactive Ingredients

Water(Aqua/Eau), Butyloctyl Salicylate, Propanediol, Benzotriazolyl Dodecyl p-Cresol, Butylene Glycol, Acrylates Copolymer, Zea Mays (Corn) Starch, Cetyl Alcohol, Pentylene Glycol, 1,2-Hexanediol, Hydroxyacetophenone, Ammonium Acryloyldimethyltaurate/VP

Copolymer, Polyamide-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroxypropyl Methylcellulose, Butylene Glycol Dicaprylate/Dicaprate, Tromethamine, Hydroxypropyl Methylcellulose Stearoxy Ether, Polyacrylate Crosspolymer-6, Disodium EDTA, Xanthan Gum, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Azelaic Acid, Sodium Stearoyl Glutamate, Xylitol, Zinc PCA, Caesalpinia Spinosa Fruit Extract, Kappaphycus Alvarezii Extract, Buddleja Officinalis Flower Extract, Centella Asiatica Leaf Extract, Fructooligosaccharides, Hyaluronic Acid/Polyisopropylacrylamide Copolymer, Ethylhexylglycerin, Lactobacillus Ferment, Lactobacillus/Soybean Ferment Extract, Leuconostoc/Radish Root Ferment Filtrate, Yeast Ferment Extract, Pinus Pinaster Bark Extract, Madecassoside, Panthenol, Centella Asiatica Extract, Asiaticoside, Madecassic Acid, Asiatic Acid

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 earty skin aging caused by the sun.
Purpose

Sunscreen

Warnings

For externall 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, especiall from 10 am-2 p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Package Label (PACKAGE LABEL)

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

Avobenzone 2.85%,

Homosalate 6.8%, Octisalate 4.5%

Inactive Ingredients (Inactive ingredients)

Water(Aqua/Eau), Butyloctyl Salicylate, Propanediol, Benzotriazolyl Dodecyl p-Cresol, Butylene Glycol, Acrylates Copolymer, Zea Mays (Corn) Starch, Cetyl Alcohol, Pentylene Glycol, 1,2-Hexanediol, Hydroxyacetophenone, Ammonium Acryloyldimethyltaurate/VP

Copolymer, Polyamide-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroxypropyl Methylcellulose, Butylene Glycol Dicaprylate/Dicaprate, Tromethamine, Hydroxypropyl Methylcellulose Stearoxy Ether, Polyacrylate Crosspolymer-6, Disodium EDTA, Xanthan Gum, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Azelaic Acid, Sodium Stearoyl Glutamate, Xylitol, Zinc PCA, Caesalpinia Spinosa Fruit Extract, Kappaphycus Alvarezii Extract, Buddleja Officinalis Flower Extract, Centella Asiatica Leaf Extract, Fructooligosaccharides, Hyaluronic Acid/Polyisopropylacrylamide Copolymer, Ethylhexylglycerin, Lactobacillus Ferment, Lactobacillus/Soybean Ferment Extract, Leuconostoc/Radish Root Ferment Filtrate, Yeast Ferment Extract, Pinus Pinaster Bark Extract, Madecassoside, Panthenol, Centella Asiatica Extract, Asiaticoside, Madecassic Acid, Asiatic Acid

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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