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
Purpose

Suncreen

Description

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

Medication Information

Warnings

For external use only



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

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

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.



Description

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

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

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

Warnings

For external use only



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

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

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.



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

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

Back to search View SPL set listing Open on DailyMed ↗

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