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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Triple Performing Facial Broad Spectrum SPF15

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:

Label2

BENEFIT TRIPLE PERFORMING FACIAL BROAD SPECTRUM SPF15 
avobenzone, octinoxate, octocrylene, sulisobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66472-043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K) SULISOBENZONE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66472-043-011 in 1 BOTTLE02/01/201910/31/2021
150.3 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/22/201510/31/2021
Labeler - Benefit Cosmetics, LLC (070826813)

Revised: 2/2022
Document Id: d9171343-f5d6-1663-e053-2995a90a4b3e
Set id: 67796e08-17c0-4401-bee3-9e64249da380
Version: 4
Effective Time: 20220228
 
Benefit Cosmetics, LLC