LIP PROTECTOR SUNSCREEN SPF15- octinoxate,zinc oxide,oxybenzone lipstick

Lip Protector Sunscreen SPF15 by

Drug Labeling and Warnings

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: OCTINOXATE(7.5% W/W), ZINC OXIDE(3.395% W/W),OXYBENZONE(3%W/W)

INDICATIONS & USAGE

DIRECTION: Apply liberally at least 15 minutes before sun exposure, alone or under lipstick. Reapply every one to three hours as needed and after swimming, eating or drinking .3

WARNINGS

WARNING : For external use only. Discontinue use if irritation or rash develops. For use under 6 month of age , consult your doctor. Keep out reach of children.

INACTIVE INGREDIENT

PETROLATUM , C12-15 ALKYL BENZOATE , PENTAETYTHRITYL TETRAISOSTEARATE , OZOKERITE , CERESIN , CETYL ALCOHOL , TOCOPHERYL ACETATE, POLYHYDROXYSTERAIC ACID,TOCOPEROL , GLYCINE SOJA (SOYBEAN) OIL , TRIETHOXYCAPRYLRLSILANE , YELLOW 5 LAKE , YELLOW 6 LAKE

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

LIP PROTECTOR SUNSCREEN SPF15  
octinoxate,zinc oxide,oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-9480
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.338 g  in 4.5 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.135 g  in 4.5 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.152 g  in 4.5 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ACETATE ION (UNII: 569DQM74SC)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
SOYBEAN OIL (UNII: 241ATL177A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-9480-0	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	03/01/2007

Labeler - Mary Kay INC. (103978839)