LIP PROTECTOR SUNSCREEN SPF15 LIP PROTECTOR SUNSCREEN SPF15 - octinoxate, oxybenzone and zinc oxide lipstick
Mary Kay 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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ACTIVE INGREDIENTS: OCTINOXATE(7.5% W/W), ZINC OXIDE(3.395% W/W),OXYBENZONE(3%W/W)

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

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.

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

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LIP PROTECTOR SUNSCREEN SPF15 LIP PROTECTOR SUNSCREEN SPF15
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51531-6948
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (Octinoxate)	Octinoxate	0.338 g in 4.5 g
Oxybenzone (Oxybenzone)	Oxybenzone	0.135 g in 4.5 g
Zinc Oxide (Zinc Oxide)	Zinc Oxide	0.152 g in 4.5 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM
ALKYL (C12-15) BENZOATE
CERESIN
CETYL ALCOHOL
ACETATE ION
POLYHYDROXYSTEARIC ACID (2300 MW)
ALPHA-TOCOPHEROL
SOYBEAN OIL
TRIETHOXYCAPRYLYLSILANE
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51531-6948-0	4.5 g in 1 CONTAINER	None

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)

Revised: 02/2011 Mary Kay INC.