pur confort spf 15

pur confort spf 15
SPL v4
SPL
SPL Set ID 2fe0656f-f924-48da-91bf-d6f3d98e8fd9
Route
topical
Published
Effective Date 2018-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (28.5 mg) homosalate (50 mg) octinoxate (70 mg) octisalate (30 mg) octocrylene (90 mg)
Inactive Ingredients
water glycerin cetyl alcohol caprylyl trisiloxane medium-chain triglycerides pentylene glycol polymethylsilsesquioxane (4.5 microns) sodium stearoyl glutamate hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) hydrogenated soybean lecithin palmitic acid propylene glycol ethylhexylglycerin levomenol .alpha.-tocopherol acetate stearalkonium hectorite xanthan gum betaine propylene carbonate edetate disodium anhydrous laminaria ochroleuca polysorbate 60 sorbitan isostearate pectin sucrose capryloyl glycine hyaluronate sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-05-01

Purpose

Sunscreen

Description

AVOBENZONE:  2.85% HOMOSALATE:  5.00% OCTINOXATE:  7.00% OCTISALATE:  3.00% OCTOCRYLENE:  9.00%


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 at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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: Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.
Other Information
  • Protect this product from excessive heat and direct sun.
  • Store below 30 C/86 F. o o
Inactive Ingredients

Water/Eau (Aqua), Glycerin, Cetyl Alcohol, Caprylyl Methicone, Caprylic/Capric Triglyceride, Pentylene Glycol, Polymethylsilsesquioxane, Sodium Stearoyl Glutamate, HDI/Trimethylol Hexyllactone Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Lecithin, Palmitic Acid, Propylene Glycol, Ethylhexylglycerin, Bisabolol, Oxidized Corn Oil, Tocopheryl Acetate, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Stearalkonium Hectorite, Fragrance (Parfum), Xanthan Gum, Betaine, Propylene Carbonate, Disodium EDTA, Laminaria Ochroleuca Extract, Polysorbate 60, Sorbitan Isostearate, Pectin, Sucrose, Glyceryl Acrylate/Acrylic Acid Copolymer, Capryloyl Glycine, Sodium Hyaluronate. 01

Description

AVOBENZONE:  2.85% HOMOSALATE:  5.00% OCTINOXATE:  7.00% OCTISALATE:  3.00% OCTOCRYLENE:  9.00%

Do Not Use

on damaged or broken skin.

Drug Facts

Package Labeling

Active Ingredients

AVOBENZONE:  2.85%

HOMOSALATE:  5.00%

OCTINOXATE:  7.00%

OCTISALATE:  3.00%

OCTOCRYLENE:  9.00%

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.


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 at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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: Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
  • Store below 30 C/86 F. o o
Inactive Ingredients (Inactive ingredients)

Water/Eau (Aqua), Glycerin, Cetyl Alcohol, Caprylyl Methicone, Caprylic/Capric Triglyceride, Pentylene Glycol, Polymethylsilsesquioxane, Sodium Stearoyl Glutamate, HDI/Trimethylol Hexyllactone Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Lecithin, Palmitic Acid, Propylene Glycol, Ethylhexylglycerin, Bisabolol, Oxidized Corn Oil, Tocopheryl Acetate, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Stearalkonium Hectorite, Fragrance (Parfum), Xanthan Gum, Betaine, Propylene Carbonate, Disodium EDTA, Laminaria Ochroleuca Extract, Polysorbate 60, Sorbitan Isostearate, Pectin, Sucrose, Glyceryl Acrylate/Acrylic Acid Copolymer, Capryloyl Glycine, Sodium Hyaluronate. 01

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Package Labeling

Active Ingredients (Active ingredients)

AVOBENZONE:  2.85%

HOMOSALATE:  5.00%

OCTINOXATE:  7.00%

OCTISALATE:  3.00%

OCTOCRYLENE:  9.00%

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. If (Keep out of reach of children. If)

product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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