Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f9ed373e-1ce0-4765-acb3-90f6e012a902
Route
TOPICAL
Published
Effective Date 2016-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.5 g) Homosalate (15 g) Octisalate (5 g) Octocrylene (1.2 g) Oxybenzone (6 g)
Inactive Ingredients
Water Stearyl Alcohol Glycerin Caprylyl Glycol Cetyl Alcohol Trolamine Carboxypolymethylene Glyceryl Monostearate Docosanol Xanthan Gum Sodium Lauryl Sarcosinate Edetate Disodium Dipropylene Glycol Butylated Hydroxytoluene Disodium Ethylene Dicocamide Peg-15 Disulfate Glyceryl Stearate Citrate Cetostearyl Alcohol Sodium Lauroyl Lactylate Vitamin A Palmitate .alpha.-tocopherol Acetate Aloe Vera Leaf Phenoxyethanol Methyldibromo Glutaronitrile Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-07-20
Description

AVOBENZONE 1.5%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 1.2%,  OXYBENZONE 6.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 1.5%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 1.2%,  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


Warning

For external use only

Directions
  • apply liberally15 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 .am. to 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

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

Active Ingredients

AVOBENZONE 1.5%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 1.2%, 

OXYBENZONE 6.0%

Inactive Ingredients


Water, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Stearyl Alcohol, Glycerin, Caprylyl Glycol, Cetyl Alcohol, Triethanolamine, Carbomer, Glyceryl Stearate, Behenyl Alcohol, Xanthan Gum, Sodium Lauroyl Sarcosinate, Disodium EDTA, Dipropylene Glycol, BHT, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glyceryl Stearate Citrate, Cetearyl Alcohol, Sodium Lauroyl Lactylate, Retinyl Palmitate, Tocopheryl Acetate, Lecithin, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methyldibromo Glutaronitrile, Methylchloroisothiazolinone, Methylisothiazolinone.







Principle Display Label


NDC 59054-880-10

Academy

SPORTS+OUTDOOR

SUNSCREEN LOTION

BROAD SPECTRUM

SPF 50

40

Water Resistant

(80 Minutes)

Hypoallergenic

UVA/UVB protection

16 FL. OZ.

(473 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

Sunscreen

Warning

For external use only

Directions
  • apply liberally15 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 .am. to 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

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

Active Ingredients

AVOBENZONE 1.5%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 1.2%, 

OXYBENZONE 6.0%

Inactive Ingredients


Water, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Stearyl Alcohol, Glycerin, Caprylyl Glycol, Cetyl Alcohol, Triethanolamine, Carbomer, Glyceryl Stearate, Behenyl Alcohol, Xanthan Gum, Sodium Lauroyl Sarcosinate, Disodium EDTA, Dipropylene Glycol, BHT, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glyceryl Stearate Citrate, Cetearyl Alcohol, Sodium Lauroyl Lactylate, Retinyl Palmitate, Tocopheryl Acetate, Lecithin, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methyldibromo Glutaronitrile, Methylchloroisothiazolinone, Methylisothiazolinone.







Principle Display Label


NDC 59054-880-10

Academy

SPORTS+OUTDOOR

SUNSCREEN LOTION

BROAD SPECTRUM

SPF 50

40

Water Resistant

(80 Minutes)

Hypoallergenic

UVA/UVB protection

16 FL. OZ.

(473 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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.632649 · Updated: 2026-03-14T22:54:23.335310