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
Purpose

Sunscreen

Description

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

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

Sunscreen

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, 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.

Description

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

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









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.

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

Sunscreen

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, 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









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.

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