Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 544b80a6-fd63-42a1-b78a-3bccbda2b3fe
Route
TOPICAL
Published
Effective Date 2016-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (2 g) Oxybenzone (6 g)
Inactive Ingredients
Water Butyloctyl Salicylate Glyceryl Monostearate Peg-100 Stearate Phenoxyethanol Vinylpyrrolidone/hexadecene Copolymer Docosanol Silicon Dioxide Trideceth-6 Dimethicone Caprylyl Trisiloxane Ethylhexyl Stearate Peg-4 Dilaurate Peg-4 Laurate Xanthan Gum Butylated Hydroxytoluene Edetate Disodium Polyethylene Glycol 200 Ethylhexylglycerin Methylparaben Propylparaben Ethylparaben Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-19
Description

AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%, OXYBENZONE 6.0%

Purpose

Suncreen

Medication Information

Purpose

Suncreen

Description

AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%, OXYBENZONE 6.0%

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



Directions
  • apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • 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 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-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin



Active Ingredients

AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%,

OXYBENZONE 6.0%

Other Information:
  • protect this product from excessive heat and direct sun

Inactive Ingredients


Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Glyceryl Stearate, PEG-100, Stearate, Phenoxyethanol, VP/Hexadecene Copolymer, Behenyl Alcohol, Silica, Trideceth-6, Sodium Polyacrylate, Dimethicone, Methylparaben, Trimethylsiloxysilicate, Fragrance, Caprylyl Methicone, Ethylhexyl Stearate, Propylparaben, PEG-4 Dilaurate, PEG-4 Laurate, BHT, Disodium EDTA, Ethylparaben, Xanthan Gum, Iodopropynyl Butylcarbamate, PEG-4, Ethylhexylglycerin.



Principle Display Panel


62296-7866-4



SUNCARE



BROAD SPECTRUM

SPF 55

WATER RESISTANT

(80 MINUTES)

LIGHTWEIGHT

SUNSCREEN LOTION

SHEER

ULTA

5 fl oz/147 ml

















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.

  • May stain some fabrics

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

Suncreen

Warnings

For external use only



Directions
  • apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • 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 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-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin



Active Ingredients

AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%,

OXYBENZONE 6.0%

Other Information: (Other information:)
  • protect this product from excessive heat and direct sun

Inactive Ingredients


Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Glyceryl Stearate, PEG-100, Stearate, Phenoxyethanol, VP/Hexadecene Copolymer, Behenyl Alcohol, Silica, Trideceth-6, Sodium Polyacrylate, Dimethicone, Methylparaben, Trimethylsiloxysilicate, Fragrance, Caprylyl Methicone, Ethylhexyl Stearate, Propylparaben, PEG-4 Dilaurate, PEG-4 Laurate, BHT, Disodium EDTA, Ethylparaben, Xanthan Gum, Iodopropynyl Butylcarbamate, PEG-4, Ethylhexylglycerin.



Principle Display Panel


62296-7866-4



SUNCARE



BROAD SPECTRUM

SPF 55

WATER RESISTANT

(80 MINUTES)

LIGHTWEIGHT

SUNSCREEN LOTION

SHEER

ULTA

5 fl oz/147 ml

















When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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

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

  • May stain some fabrics

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:06.954273 · Updated: 2026-03-14T22:54:20.908479