30d53b8a-7e35-0b2b-e063-6294a90aa8df

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

Purpose

Sunscreen

Description

Avobenzone 2.85%, Homosalate 6.8%, Octisalate 4.5%


Medication Information

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.
Purpose

Sunscreen

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

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.
Package Label

Active Ingredients

Avobenzone 2.85%,

Homosalate 6.8%, Octisalate 4.5%

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

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.
Purpose

Sunscreen

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.
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, 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

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.
Package Label (PACKAGE LABEL)

Active Ingredients (Active ingredients)

Avobenzone 2.85%,

Homosalate 6.8%, Octisalate 4.5%

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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