AGE DEFENSE FOR EYES 5 IN 1- zinc oxide and titanium dioxide lotion

Age Defense for Eyes by

Drug Labeling and Warnings

Age Defense for Eyes by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
Zinc Oxide 6.5%	Sunscreen
Titanium Oxide 6.4%	Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & other sunscreen measures including:
  • Limit time in the sun especially from 10 a.m. to 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor.

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Purified Water, Caprylyl Methicone, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Dimethicone Crosspolymer, Glycerin, Isododecane, Dimethicone, Alumina, Hydrogen Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides, Tin Oxide, Sodium Hyaluronate, Acetyl Hexapeptide-8, Leontopodium Alpinum Callus Culture Extract, Dunaliella Salina Extract, Macrocystis Pyrifera (Kelp) Extract, Panthenol, Tocopheryl Acetate, Palmitoyl Tripeptide-5, Hydrolyzed Vegetable Protein, Ascophyllum Nodosum Extract, Asparagopsis Armata Extract, Sucrose, Xanthan Gum, Mica, Silica, PVP, Triethoxycaprylylsilane, Sorbitol, Phenyl Trimethicone, Sodium Chloride, Phenoxyethanol, Disodium EDTA, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL - 8.5 ml Tube Box

AGE DEFENSE
FOR THE EYES
5-IN-1

BROAD SPECTRUM UVA/UVB SPF 50+
PROTECT + CONCEAL
WATER/SWEAT RESISTANT (80 MIN)

Net 0.29 fl. oz. (8.5 ml)

INGREDIENTS AND APPEARANCE

AGE DEFENSE FOR EYES  5 IN 1
zinc oxide and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	65 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S) (UNII: KB7T6C99UP)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYDROGEN DIMETHICONE (45 CST) (UNII: L2AFM6S5VW)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STANNIC OXIDE (UNII: KM7N50LOS6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ACETYL HEXAPEPTIDE-8 AMIDE (UNII: L4EL31FWIL)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)
ASPARAGOPSIS ARMATA (UNII: 2936KN6I1G)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBITOL (UNII: 506T60A25R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-126-01	1 in 1 BOX	05/27/2020
1		8.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	05/27/2020

Labeler - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-126)