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

PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN by

Drug Labeling and Warnings

PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 6.1 % W/W

Zinc Oxide 5.6 % W/W

Purpose

Sunscreen

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 For Sunscreen Use:

• 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. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor.

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

• Protect this product from excessive heat and direct sun
• Store at room temperature

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 - 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)

INGREDIENTS AND APPEARANCE

PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2075-1	1 in 1 BOX	02/01/2017
1	NDC: 67938-2075-2	50 mL in 1 BOTTLE; 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	02/01/2017

Labeler - ELIZABETH ARDEN, INC (849222187)