NEW LIP PROTECTOR SUNSCREEN SPF15- octinoxate,avobenzone,octocrylene lipstick

New Lip Protector Sunscreen SPF15 by

Drug Labeling and Warnings

New Lip Protector Sunscreen SPF15 by is a Otc medication manufactured, distributed, or labeled by Mary Kay INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: AVOBENZONE 2.5% OCTINOXATE 2.0% OCTOCRYLENE 6.0%

INDICATIONS & USAGE

DIRECTION: Apply liberally at least 15 minutes before sun exposure, use a water resistant sunscreen if swimming or sweating, reapply at least every 2hours.

                   Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk,regulary use a sunscreen with a broad spectrum SPF of 15 or

                   higher and other sun protection measures including. Limit time in sun, especially from 10 a.m. - 2 p.m. wear long - sleeve shirts pants,hats,and sunglasses.

WARNINGS

WARNING : For external use only. Do not use on damage or broken skin. When using this product keep out of eyes. Rinse with water to remove.

INACTIVE INGREDIENT

HELIANTHUS ANNUUS(SUNFLOWER)SEED OIL, PENTAETYTHRITYL TETRAISOSTEARATE , OZOKERITE, CETYL ETHYLHEXANOATE , CERESIN , C12-15 ALKYL BENZOATE ,  CARTHAMUS TINTORIUS (SAFFLOWER) SEED OIL , ETHYLHEXYL METHOXYCRYLENE, CETYL ALCOHOL , STYRENE / BUTADIENE COPOLYMER , TOCOPEROL ,TOCOPHERYL ACETATE, TBHQ

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEW LIP PROTECTOR SUNSCREEN SPF15  
octinoxate,avobenzone,octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-9500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.09 g  in 4.5 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.1125 g  in 4.5 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.27 g  in 4.5 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
SAFFLOWER OIL (UNII: 65UEH262IS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-9500-1	4.5 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2012

Labeler - Mary Kay INC. (103978839)