PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion 
ELIZABETH ARDEN, INC

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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Drug Facts

Active Ingredients

Titanium Dioxide 6.1 % W/W

Zinc Oxide 5.6 % W/W

Purpose

Sunscreen

Sunscreen

Uses

Warnings

  • 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 For Sunscreen Use:

Inactive Ingredients

WATER/AQUA/EAU, CYCLOPENTASILOXANE, ISODODECANE, C12-15 ALKYL BENZOATE, CAPRYLYL METHICONE, DIMETHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, RICINOLETH-40, ETHOXYDIGLYCOL, CARNOSINE, ACETYL FARNESYLCYSTEINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ALLYL CAPROATE, ARABIDOPSIS THALIANA EXTRACT, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CHONDRUS CRISPUS EXTRACT, DIPROPYLENE GLYCOL, ERGOTHIONEINE, ETHYL DECADIENOATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROGEN DIMETHICONE, LECITHIN, METHYLDIHYDROJASMONATE, METHYLENEDIOXYPHENYL METHYLPROPANAL, MICROCOCCUS LYSATE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SILICA, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, IRON OXIDES (CI 77491, CI 77492, CI 77499).

Other Information

Questions or comments?

Call toll free 1-844-273-3679

Principal Display Panel - Bottle Label

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR

Broad Spectrum
SPF 50 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

PHYSICAL SUNSCREEN
UNIVERSAL TINT

RECOMMENDED

SKIN
CANCER
FOUNDATION

DAILY USE

RECOMMENDED AS
AN EFFECTIVE
BROAD SPECTRUM
SUNSCREEN

1.7 FL. OZ. (50 ml)

Principal Display Panel - Bottle Label

Principal Display Panel - Carton Label

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR

Broad Spectrum
SPF 50 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

PHYSICAL SUNSCREEN
UNIVERSAL TINT

RECOMMENDED

SKIN
CANCER
FOUNDATION

DAILY USE

RECOMMENDED AS
AN EFFECTIVE
BROAD SPECTRUM
SUNSCREEN

1.7 FL. OZ. (50 ml)

Principal Display Panel - Carton Label
PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-2075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE.25803 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE.31416 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ISODODECANE (UNII: A8289P68Y2)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
RICINOLETH-40 (UNII: 6S0J4W9IQY)  
CARNOSINE (UNII: 8HO6PVN24W)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ACETYL FARNESYLCYSTEINE (UNII: KK6984C8O3)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
ALLYL HEXANOATE (UNII: 3VH84A363D)  
ETHYL 2,4-DECADIENOATE, (2E,4Z)- (UNII: 79P6KS9Y5Z)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-2075-11 in 1 BOX02/01/2017
1NDC:67938-2075-250 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2017
Labeler - ELIZABETH ARDEN, INC (849222187)

Revised: 2/2017
Document Id: 9f92c5e4-8317-4a87-a581-8f81204b5e28
Set id: 6b1920aa-ec6a-4c8b-b8b8-2c621f959e94
Version: 1
Effective Time: 20170201
 
ELIZABETH ARDEN, INC