drug facts

drug facts
SPL v1
SPL
SPL Set ID ff7473ee-b90d-4102-a483-0c23b30a3cda
Route
topical
Published
Effective Date 2015-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (1.8 g) homosalate (7 g) octocrylene (5 g)
Inactive Ingredients
water cetostearyl alcohol stearyl alcohol glycerin phenoxyethanol caprylyl glycol cetyl alcohol ceteth-10 phosphate dihexadecyl phosphate coco glucoside methylparaben propylparaben sodium hydroxide edetate disodium hydrogenated methyl abietate sodium ascorbyl phosphate .alpha.-tocopherol acetate aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-08-11
Purpose

Sunscreen

Description

Avobenzone 1.8%, Homosalate 7.0%, 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

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

Inactive Ingredients

Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Hydrogenated Methyl Abietate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Description

Avobenzone 1.8%, Homosalate 7.0%, Octocrylene 5.0%

Principal Display Panel

62296-2273-2

SUNCARE

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES) OIL-FREE

SUNSCREEN LOTION

ULTA

3 fl oz/88 mL

62296-2273-4

SUNCARE

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES) OIL FREE

SUNSCREEN LOTION

ULTA

6 flo oz/176 mL

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 1.8%, Homosalate 7.0%, Octocrylene 5.0%



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

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

Inactive Ingredients

Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Hydrogenated Methyl Abietate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

62296-2273-2

SUNCARE

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES) OIL-FREE

SUNSCREEN LOTION

ULTA

3 fl oz/88 mL

62296-2273-4

SUNCARE

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES) OIL FREE

SUNSCREEN LOTION

ULTA

6 flo oz/176 mL

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 1.8%, Homosalate 7.0%, Octocrylene 5.0%



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: 2026-02-15T11:56:05.668487 · Updated: 2026-03-14T22:54:18.927073