MANGO BEBE LIP CARE SPF15 RED MANGO

Dosage form: stick
Ingredients: OCTINOXATE 0.21g in 3.5g, OCTISALATE 0.105g in 3.5g, TITANIUM DIOXIDE 0.01g in 3.5g
Labeler: NATURE REPUBLIC CO., LTD.
NDC Code: 51346-026

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.

ACTIVE INGREDIENT

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 6%, ETHYLHEXYL SALICYLATE 3%, TITANIUM DIOXIDE 0.3%

INACTIVE INGREDIENT

Inactive Ingredients:
PETROLATUM, POLYGLYCERYL-2 TRIISOSTEARATE, DIISOSTEARYL MALATE, JOJOBA ESTERS, HYDROGENATED POLYISOBUTENE, MICROCRYSTALLINE WAX, POLYETHYLENE, MEADOWFOAM DELTA-LACTONE, PHYTOSTERYL HYDROXYSTEARATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, HYDROGENATED COCO-GLYCERIDES, CERESIN, MANGIFERA INDICA (MANGO) SEED BUTTER, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, FRAGRANCE, TOCOPHERYL ACETATE, RED 7, BHT, IRON OXIDES

PURPOSE

Purpose: Hydrates lips with a variety of Mango scents.

WARNINGS

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rash appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use: Smoothly apply on lips for conditioned and moistful lips.

DOSAGE AND ADMINISTRATION

How to Use: Smoothly apply on lips for conditioned and moistful lips.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

MANGO BEBE LIP CARE  SPF15 RED MANGO
octinoxate, octisalate, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-026
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.21 g  in 3.5 g
OCTISALATE (OCTISALATE) OCTISALATE0.105 g  in 3.5 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.01 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
MICROCRYSTALLINE WAX 
CERESIN 
MANGIFERA INDICA SEED BUTTER 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage Description
1NDC:51346-026-013.5 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2012
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIOperations
NATURE REPUBLIC CO., LTD.631172020manufacture(51346-026)

Revised: 08/2012
 
NATURE REPUBLIC CO., LTD.

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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