BENEFIT TRIPLE PERFORMING FACIAL EMULSION BROAD SPECTRUM SPF 15- avobenzone, octocrylene, octinoxate, sulisobenzone emulsion

Benefit Triple Performing Facial Emulsion Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Benefit Triple Performing Facial Emulsion Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Benefit Cosmetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Benefit Triple Performing Facial Emulsion Broad Spectrum SPF 15

Active Ingredients

Avobenzone 3.00%
Octocrylene 2.00%
Octinoxate 7.49%
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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially 10 a.m. till 2 p.m.
• Wear long-sleeved shirts, hats, and sunglasses.
  

Other information

Protect the product in this container from excessive heat or direct sun.  Do not use if top band and bottom safety seal on unit carton is missing or broken.

Inactive ingredients

Water, Glycerin, Dicaprylyl Carbonate, Butylene Glycol, Pentylene Glycol, Diglycerin, C14-22 Alcohols, Polymethyl Methacrylate, Silica, Bataira, Steareth-21, Phenoxyethanol, Phenyl Trimethicone, Coco-glucoside, Fragrance, C12-20 Alkyl Glucoside, Coconut Alcohol, Polyacrylamide, C13-14 Isoparaffin, Sodium Hydroxide, De, Tetrasodium EDTA, Tocopheryl Acetate, Carbomer, Xanthan Gum, Laureth-7, Xylitylglucoside, Linalool, Anhydroxylitol, BHT, Xyltol, Hexyl Cinnamal, Linoate, Augi Tulestica Extract, Hyaluronic Acid, Sodium Hyaluronate.

SPL UNCLASSIFIED SECTION

You may not know you're dehydrated, but your skin does.   TRIPLE PERFORMING FACIAL SUNSCREEN LOTION broad spectrum SPF 15 hydrates, protects and comforts the skin with an oil-free, lightweight formula.  Contains exclusive ultra-moisturizing ingredients to help capture and maintain water on the skin's surface.  DISTRIBUTED BY  BENEFIT COSMETICS, LLC   225 BUSH STREET, 20TH FLOOR, SAN FRANCISCO, CA 94104 USA   MADE IN FRANCE benefitcosmetics.com

PRINCIPAL DISPLAY PANEL

moisturize   TRIPLE PERFORMING FACIAL EMULSION  OIL-FREE benefit    SHEER OIL-FREE BROAD SPECTRUM SPF 15  FACIAL SUNSCREEN LOTION   FOR ALL SKIN TYPES   1.7 fl oz (50.3 mL)

Product Labels

INGREDIENTS AND APPEARANCE

BENEFIT TRIPLE PERFORMING FACIAL EMULSION BROAD SPECTRUM SPF 15 
avobenzone, octocrylene, octinoxate, sulisobenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66472-023
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURETH-7 (UNII: Z95S6G8201)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONIC ACID (UNII: S270N0TRQY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66472-023-01	1 in 1 CARTON	07/28/2011
1		50.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/28/2011

Labeler - Benefit Cosmetics, LLC (070826813)