New Lip Protector Sunscreen SPF15

Dosage form: lipstick
Ingredients: Octinoxate 0.09g in 4.5g, Avobenzone 0.1125g in 4.5g, Octocrylene 0.27g in 4.5g
Labeler: Mary Kay INC.
NDC Code: 51531-9500

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.

New Lip Protector Sunscreen SPF15

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

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.

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.


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


NEW LIP PROTECTOR SUNSCREEN SPF15  
octinoxate,avobenzone,octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-9500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.09 g  in 4.5 g
Avobenzone (Avobenzone) Avobenzone0.1125 g  in 4.5 g
Octocrylene (Octocrylene) Octocrylene0.27 g  in 4.5 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL 
CERESIN 
CETYL ALCOHOL  
CETYL ETHYLHEXANOATE 
ALKYL (C12-15) BENZOATE 
ALPHA-TOCOPHEROL 
SAFFLOWER OIL 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:51531-9500-14.5 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2012
Labeler - Mary Kay INC. (103978839)

Revised: 03/2012
 
Mary Kay INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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