BENEFIT TRIPLE PERFORMING FACIAL BROAD SPECTRUM SPF15- avobenzone, octinoxate, octocrylene, sulisobenzone cream

BENEFIT Triple Performing Facial Broad Spectrum SPF15 by

Drug Labeling and Warnings

BENEFIT Triple Performing Facial Broad Spectrum SPF15 by is a Otc medication manufactured, distributed, or labeled by Benefit Cosmetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3.00%
Octinoxate 7.49%
Octocrylene 2.00%
Sulisobenzone 1.50%

Purpose

Sunscreen

Use

• 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 swallowed, get medical help or contact 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.
• Children under 6 months of age: ask a doctor.
• Skin 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 value of 15 or higher and other sun protection measures including:

     Limit time in the sun, especially from 10 a.m. till 2 p.m.

     Wear long-sleeved shirts, pants, hats & sun glasses.

Other information

Protect the product in this container from excessive heat or direct sun.

Inactive ingredients

Aqua (Water), Glycerin, Dicaprylyl Carbonate, Butylene Glycol, Pentylene Glycol, Diglycerin, C14-22 Alcohols, Polymethyl Methacrylate, Silica, Betaine, Steareth-21, Phenoxyethanol, Phenyl Trimethicone, Coco-Glucoside, Parfum (Fragrance), C12-20 Alkyl Glucoside, Coconut Alcohol, Polyacrylamide, C13-14 Isoparaffin, Sodium Hydroxide, Decyloxazolidinone, Tetrasodium EDTA, Tocopheryl Acetate, Carbomer, Xanthan Gum, Laureth-7, Xylitylglucoside, Linalool, Anhydroxylitol, BHT, Xylitol, Hexyl Cinnamal, Limonene, Hyaluronic Acid, Sodium Hyaluronate, Tocopherol.

Package Labeling:

INGREDIENTS AND APPEARANCE

BENEFIT TRIPLE PERFORMING FACIAL BROAD SPECTRUM SPF15 
avobenzone, octinoxate, octocrylene, sulisobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66472-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K)	SULISOBENZONE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIGLYCERIN (UNII: 3YC120743U)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BETAINE (UNII: 3SCV180C9W)
STEARETH-21 (UNII: 53J3F32P58)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
COCO GLUCOSIDE (UNII: ICS790225B)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DECYLOXAZOLIDINONE (UNII: 95K9FHM51V)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURETH-7 (UNII: Z95S6G8201)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
XYLITOL (UNII: VCQ006KQ1E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYALURONIC ACID (UNII: S270N0TRQY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66472-043-01	1 in 1 BOTTLE	02/01/2019
1		50.3 mL in 1 PACKAGE; 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	08/22/2015

Labeler - Benefit Cosmetics, LLC (070826813)