Smooth Minerals Lipgloss

Dosage form: lipstick
Ingredients: OCTINOXATE 175mg in 3.5g, OXYBENZONE 105mg in 3.5g
Labeler: Avon Products, Inc.
NDC Code: 10096-0202

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.

DIRECTIONS: Apply liberally before sun
exposure and as needed.

WARNING:
Discontinue use if skin irritation
develops or increases. If irritation
persists, consult a health care
practitioner.

Uses: Helps prevent sunburn. Higher SPF
gives more sunburn protection.

ACTIVE INGREDIENTS/INGRÉDIENTS ACTIFS: OCTINOXATE 5.00%,
OXYBENZONE 3.00%.

     INACTIVE INGREDIENTS / INGRÉDIENTS INACTIFS:

     POLYBUTENE
     DIISOSTEARYL FUMARATE
     LANOLIN
     SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
     DIISOSTEARYL MALATE
     PETROLATUM
     MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE
     BARIUM SULFATE
     CALCIUM SODIUM BOROSILICATE
     SILICA
     ALOE BARBADENSIS LEAF EXTRACT
     BUTYROSPERMUM PARKII (SHEA) BUTTER
     THEOBROMA CACAO (COCOA) SEED BUTTER
     SACCHAROMYCES/COPPER FERMENT
     SACCHAROMYCES/MAGNESIUM FERMENT
     SACCHAROMYCES/ZINC FERMENT
     SACCHAROMYCES/MALACHITE FERMENT
     SACCHAROMYCES/TOURMALINE FERMENT
     ETHYLENE/PROPYLENE/STYRENE COPOLYMER
     ISOPROPYL ISOSTEARATE
     OZOKERITE
     EUPHORBIA CERIFERA (CANDELILLA) WAX/CIRE DE CANDELILLA
     TOCOPHERYL ACETATE
     BUTYLENE/ETHYLENE/STYRENE COPOLYMER
     LECITHIN
     C12-15 ALKYL BENZOATE
     RETINYL PALMITATE
     ASCORBYL PALMITATE
     BETA-CAROTENE

MAY CONTAIN:
       MICA/CI 77019
       TITANIUM DIOXIDE/CI 77891
       CARMINE/CI 75470
       IRON OXIDES
       BISMUTH OXYCHLORIDE/CI 77163

SMOOTH MINERALS  LIPGLOSS
octinoxate, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE175 mg  in 3.5 g
OXYBENZONE (OXYBENZONE) OXYBENZONE105 mg  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN 
PETROLATUM 
BARIUM SULFATE 
C12-15 ALKYL BENZOATE 
ASCORBYL PALMITATE  
BETA CAROTENE 
MICA 
TITANIUM DIOXIDE 
BISMUTH OXYCHLORIDE 
Packaging
#Item CodePackage Description
1NDC:10096-0202-13.5 g in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/02/2010
Labeler - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIOperations
Avon Products, Inc.001807106manufacture

Revised: 06/2010
 
Avon Products, 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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