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

Description

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen



Description

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 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

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

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

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%



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

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

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

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%



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

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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