drug facts

drug facts
SPL v1
SPL
SPL Set ID 5d32455c-50e4-4ce8-b9c0-1761d9a6cc08
Route
topical
Published
Effective Date 2015-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octocrylene (6 g)
Inactive Ingredients
water cetostearyl alcohol stearyl alcohol glycerin phenoxyethanol caprylyl glycol cetyl alcohol ceteth-10 phosphate dihexadecyl phosphate coco glucoside methylparaben xanthan gum sodium ascorbyl phosphate .alpha.-tocopherol acetate aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-08-17

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 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

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 3.0%, Homosalate 10.0%, Octocrylene 6.0%

Principal Display Panel

62296-2275-4

SUNCARE

BROAD SPECTRUM SPF 50+

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 3.0%, Homosalate 10.0%, Octocrylene 6.0%



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

62296-2275-4

SUNCARE

BROAD SPECTRUM SPF 50+

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 (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%



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

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