PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, octisalate, avobenzone, zinc oxide lotion

PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN by

Drug Labeling and Warnings

PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Triple Protection Factor Lip Balm provides ultimate lip protection with SPF 30, DNA Enzyme Complex™ + Antioxidants.

Unique lip balm that nourishes and conditions, creating smooth, healthy-looking lips.

Use Directions:

Apply generously and evenly to lips prior to sun exposure.

Reapply frequently to maintain protection.

IMPORTANT:

DO NOT STAY TOO LONG IN THE SUN, EVEN WHILE USING A SUNSCREEN PRODUCT. KEEP BABIES AND YOUNG CHILDREN OUT OF DIRECT SUNLIGHT. OVEREXPOSURE TO THE SUN IS A SERIOUS, HEALTH THREAT.

Store at room temperature.

Clinically and Dermatologist Tested

• Non-Comedogenic
• Fragrance Free
• Paraben Free

INGREDIENTS:

PETROLATUM, BEESWAX/CERA ALBA/CIRE D'ABEILLE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, BUTYROSPERMUM PARKII (SHEA) BUTTER, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, RICINUS COMMUNIS (CASTOR) SEED OIL, POLYBUTENE, BUTYL METHOXYDIBENZOYLMETHANE, NYLON-12, GLYCERETH-26, BUTYLOCTYL SALICYLATE, DIOCTYLDODECYL DODECANEDIOATE, ZINC OXIDE, C12-15 ALKYL BENZOATE, LANOLIN, SQUALANE, ACETYL FARNESYLCYSTEINE, ARABIDOPSIS THALIANA EXTRACT, ASTROCARYUM MURUMURU SEED BUTTER, BISABOLOL, CARNOSINE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, ERGOTHIONEINE, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LECITHIN, LINOLEIC ACID, LINOLENIC ACID, MICROCOCCUS LYSATE, PLANKTON EXTRACT, RETINYL PALMITATE, RICINOLETH-40, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/AQUA/EAU, BHT, PHENOXYETHANOL.

Elizabeth Arden, London

Made in U.S.A.

Distributed by: Beauty Partner

Enterprise, S.r.l., Rome, 00144, IT

Principal Display Panel - Bottle Label

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR
LIP BALM

Broad Spectrum
SPF 30 Sunscreen

HIGH PROTECTION
Cream

UVA

14.ge

Principal Display Panel - Carton Label

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR
LIP BALM

Broad Spectrum
SPF 30 Sunscreen

HIGH PROTECTION
Cream

UVA

14.ge

INGREDIENTS AND APPEARANCE

PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate, octisalate, avobenzone, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.065 g  in 14.2 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	.71 g  in 14.2 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	.426 g  in 14.2 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.142 g  in 14.2 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SHEA BUTTER (UNII: K49155WL9Y)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERETH-26 (UNII: NNE56F2N14)
NYLON-12 (UNII: 446U8J075B)
DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SQUALANE (UNII: GW89575KF9)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
LANOLIN (UNII: 7EV65EAW6H)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RICINOLETH-40 (UNII: 6S0J4W9IQY)
LEVOMENOL (UNII: 24WE03BX2T)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ACETYL FARNESYLCYSTEINE (UNII: KK6984C8O3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CARNAUBA WAX (UNII: R12CBM0EIZ)
LINOLENIC ACID (UNII: 0RBV727H71)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARNOSINE (UNII: 8HO6PVN24W)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
HONEY (UNII: Y9H1V576FH)
ERGOTHIONEINE (UNII: BDZ3DQM98W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2082-1	1 in 1 BOX	02/01/2017
1	NDC: 67938-2082-2	14.2 g 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)