Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ad3cce65-abd8-4201-8f94-bc39f072c63c
Route
TOPICAL
Published
Effective Date 2016-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Homosalate (10 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Water Ethylhexyl Palmitate Sorbitol Benzyl Alcohol Dimethicone Chlorphenesin Glyceryl Monostearate Peg-100 Stearate Carboxypolymethylene Tocopherol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-25
Description

AVOBENZONE 2.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 5.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 2.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 5.0%

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 2.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 5.0%

Other Information:

protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Carbomer, Tocopherol, Aloe Barbadensis Leaf Juice Powder.

Principal Display Panel


62296-8210-4



SUNCARE



BROAD SPECTRUM SPF 15



WATER RESISTANT

(80 MINUTES)

OIL-FREE

SUNSCREEN LOTION



ULTA

6 fl oz/176 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

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 2.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 5.0%

Other Information: (Other information:)

protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Carbomer, Tocopherol, Aloe Barbadensis Leaf Juice Powder.

Principal Display Panel


62296-8210-4



SUNCARE



BROAD SPECTRUM SPF 15



WATER RESISTANT

(80 MINUTES)

OIL-FREE

SUNSCREEN LOTION



ULTA

6 fl oz/176 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: 2026-02-15T11:56:05.667263 · Updated: 2026-03-14T22:54:18.927073