PUR CONFORT SPF 15- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

Pur Confort SPF 15 by

Drug Labeling and Warnings

Pur Confort SPF 15 by is a Otc medication manufactured, distributed, or labeled by Guinot. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

AVOBENZONE:  2.85%

HOMOSALATE:  5.00%

OCTINOXATE:  7.00%

OCTISALATE:  3.00%

OCTOCRYLENE:  9.00%

Purpose

Sunscreen

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.

Do not use

on damaged or broken skin.

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.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• 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. 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 oC/86 oF.

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

Package Labeling

INGREDIENTS AND APPEARANCE

PUR CONFORT SPF 15 
avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54181-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PALMITIC ACID (UNII: 2V16EO95H1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
XANTHAN GUM (UNII: TTV12P4NEE)
BETAINE (UNII: 3SCV180C9W)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PECTIN (UNII: 89NA02M4RX)
SUCROSE (UNII: C151H8M554)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54181-015-50	1 in 1 BOX	05/01/2018
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2018

Labeler - Guinot (763667185)