ANEW SOLAR ADVANCE EYE AND LIP SUNSCREEN- titanium dioxide, zinc oxide cream

Anew Solar Advance by

Drug Labeling and Warnings

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

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Eye Cream Sunscreen To Use: Apply
evenly and smooth over upper eyelid,
under eye area, and along crow’s feet
before sun exposure and as needed.
Children under 6 months of age: ask a
doctor.

Warning: When using this
product, keep out of eyes. Rinse with
water to remove. Stop use and ask a
doctor if rash or irritation develops and
lasts. For external use only. Keep out of
reach of children.

DOSAGE & ADMINISTRATION

Glossy Lip Tint Sunscreen To Use:
Smooth evenly over lips before sun
exposure with fingertip.

Warning: Stop
use if rash occurs. Keep out of reach of
children.

INDICATIONS & USAGE

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

ACTIVE INGREDIENT

EYE CREAM ACTIVE
INGREDIENTS/INGREDIENTES
ACTIVOS DE LA
CREMA PARA LOS OJOS:
TITANIUM DIOXIDE 3.1%,
ZINC OXIDE 6.9%.

OTHER INGREDIENTS/
OTROS INGREDIENTES:
WATER/EAU, DIMETHICONE,
GLYCERIN, SIMMONDSIA
CHINENSIS (JOJOBA) SEED
OIL, DIMETHICONE CROSSPOLYMER,
PROPYLENE
GLYCOL, ISOCETYL STEAROYL
STEARATE, ISODECYL
ISONONANOATE, PHENYL
TRIMETHICONE, MAGNESIUM
SULFATE, VP/HEXADECENE
COPOLYMER, PEG-10
DIMETHICONE, LAURYL
PEG-9 POLYDIMETHYLSILOXYETHYL
DIMETHICONE,
THIODIPROPIONIC ACID, GLYCINE
SOJA (SOYBEAN) SEED
EXTRACT, PHAEODACTYLUM
TRICORNUTUM EXTRACT,
ORYZANOL, FOENICULUM
VULGARE (FENNEL) FRUIT EXTRACT,
DAUCUS CAROTA
SATIVA (CARROT) ROOT EXTRACT,
GLYCINE MAX (SOYBEAN)
SYMBIOSOME EXTRACT,
TOCOPHEROL, TOCOPHERYL
ACETATE, POLYESTER-
8, CAPRYLIC/CAPRIC
TRIGLYCERIDE, SILICA, HYDRATED
SILICA, POLYMETHYL
METHACRYLATE, ALUMINUM
HYDROXIDE, DIMETHICONE/
METHICONE COPOLYMER,
DIMETHICONE/DIVINYLDIMETHICONE/
SILSESQUIOXANE
CROSSPOLYMER,POLYSORBATE 20, POLYSORBATE
80, GLYCERYL STEARATE,
POLYHYDROXYSTEARIC
ACID, PEG-30 DIPOLYHYDROXYSTEARATE,
TRIETHOXYCAPRYLYLSILANE,
ISOHEXADECANE, AMMONIUM
POLYACRYLOYLDIMETHYL
TAURATE, AMMONIUM
HYDROXIDE, CAPRYLYL
GLYCOL, METHYLPARABEN,
IMIDAZOLIDINYL UREA,
DISODIUM EDTA.

ACTIVE INGREDIENT

GLOSSY LIP TINT
ACTIVE INGREDIENTS/
INGREDIENTES ACTIVOS
DEL BRILLO LABIAL: TITANIUM
DIOXIDE 3.3%,
ZINC OXIDE 7.2%.

OTHER INGREDIENTS/
OTROS INGREDIENTES:
POLYBUTENE, BIS-DIGLYCERYL
POLYACYLADIPATE-2,
C18-36 ACID TRIGLYCERIDE,
SIMMONDSIA CHINENSIS
(JOJOBA) SEED OIL, PHENYL
TRIMETHICONE, ISOCETYL
STEAROYL STEARATE, ISODECYL
ISONONANOATE, DIISOSTEARYL
FUMARATE,
KAEMPFERIA GALANGA
ROOT EXTRACT, GLYCINE
SOJA (SOYBEAN) SEED EXTRACT,
PHAEODACTYLUM
TRICORNUTUM EXTRACT,
ORYZANOL, FOENICULUM
VULGARE (FENNEL) FRUIT EXTRACT,
DAUCUS CAROTA
SATIVA (CARROT) ROOT EXTRACT,
DILAURYL THIODIPROPIONATE,
TOCOPHEROL,
GLYCERIN, WATER/EAU,
POLYESTER-8, POLYHYDROXYSTEARIC
ACID, GLYCERYL
STEARATE, HYDRATED
SILICA, CAPRYLIC/CAPRIC
TRIGLYCERIDE, DIMETHICONE/
METHICONE COPOLYMER,
ALUMINUM HYDROXIDE,
TRIETHOXYCAPRYLYLSILANE,
CAPRYLYL GLYCOL,
PARFUM/FRAGRANCE, IRON
OXIDES, MICA/CI 77019,
CARMINE/CI 75470.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW SOLAR ADVANCE  EYE AND LIP SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.155 g  in 5 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.345 g  in 5 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.165 g  in 5 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.36 g  in 5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ISOHEXADECANE (UNII: 918X1OUF1E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLPARABEN (UNII: A2I8C7HI9T)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0241-3	1 in 1 CARTON
1	NDC: 10096-0241-1	5 g in 1 TUBE, WITH APPLICATOR
2	NDC: 10096-0241-3	1 in 1 CARTON
2	NDC: 10096-0241-2	5 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/21/2010

Labeler - Avon Products, Inc. (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc.		005149471	manufacture