HEALTHY MAKEUP- octinoxate lipstick

Healthy Makeup by

Drug Labeling and Warnings

Healthy Makeup by is a Otc medication manufactured, distributed, or labeled by Avon Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

DIRECTIONS: Apply liberally before sun
exposure and as needed.

WARNINGS

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

ACTIVE INGREDIENT

ACTIVE INGREDIENT/INGREDIENT ACTIF:

OCTINOXATE 7.5%

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

    INACTIVE INGREDIENTS/INGREDIENTS INACTIFS:

     DIISOSTEARYL FUMARATE
     SQUALANE
     POLYBUTENE
     BARIUM SULFATE
     OZOKERITE
     MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE
     DI-C12-15 ALKYL FUMARATE
     POLYETHYLENE
     ZEA MAYS (CORN) STARCH
     CETYL ALCOHOL
     PETROLATUM
     CALCIUM SODIUM BOROSILICATE
     SILICA
     PUNICA GRANATUM FRUIT JUICE
     GLYCINE SOJA (SOYBEAN) OIL
     OLEA EUROPAEA (OLIVE) LEAF EXTRACT
     COLLAGEN
     RETINOL
     ALOE BARBADENSIS LEAF JUICE
     BEESWAX/CIRE D'ABEILLE
     CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE
     CAPRYLYL GLYCOL
     GLYCERIN
     HYDROGENATED CASTOR OIL
     BEHENYL ERUCATE
     LAUROYL LYSINE
     ACRYLATES COPOLYMER
     ALLANTOIN
     ALOE BARBADENSIS LEAF EXTRACT
     ALLYL METHACRYLATES CROSSPOLYMER
     LECITHIN
     PARFUM/FRAGRANCE
     PHENYL TRIMETHICONE
     PEG-80 SORBITAN LAURATE
     ACRYLATES/CARBAMATE COPOLYMER
     C12-15 ALKYL BENZOATE
     WATER/EAU
     TOCOPHERYL ACETATE
     TIN OXIDE
     ETHYLHEXYL PALMITATE
     RETINYL PALMITATE
     HYALURONIC ACID
     Biotin/Folic Acid/Cyanocobalamin/Niacinamide/Pantothenic Acid/Pyridoxine/Riboflavin/Thiamine/Yeast Polypeptides
     TRIBEHENIN
     SORBITAN ISOSTEARATE
     TOCOPHEROL
     ASCORBYL PALMITATE
     BETA-CAROTENE
     PALMITOYL OLIGOPEPTIDE

MAY CONTAIN:
       MICA/CI 77019
       RED 7 LAKE
       TITANIUM DIOXIDE/CI 77891
       IRON OXIDES
       RED 6/CI 15850
       RED 33 LAKE/CI 17200
       YELLOW 6 LAKE/CI 15985
       YELLOW 5 LAKE/CI 19140
       RED 6 LAKE/CI 15850
       RED 27 LAKE/CI 45410
       BLUE 1 LAKE/CI 42090
       CARMINE/CI 75470

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTHY MAKEUP 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	225 mg  in 3 g

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
RETINOL (UNII: G2SH0XKK91)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ALLANTOIN (UNII: 344S277G0Z)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYALURONIC ACID (UNII: S270N0TRQY)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETA CAROTENE (UNII: 01YAE03M7J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0216-1	3 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/10/2010

Labeler - Avon Products, Inc. (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc.		001807106	manufacture