ERYFOTONA AGELESS- zinc oxide lotion

Eryfotona Ageless by

Drug Labeling and Warnings

Eryfotona Ageless by is a Otc medication manufactured, distributed, or labeled by ISDIN Corp., Laboratoris Feltor. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 10.7%

Purpose

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.

Warning

• 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 doctor if rash occurs.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• During sun exposure, reapply:
  • after 40 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours.
• Sun Protection Measures: Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.- 2 p.m.
  • wear long- sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor.

Other information

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

Inactive ingredients

Water, Diethylhexyl Carbonate, Dibutyl Adipate, Cyclopentasiloxane, Dicaprylyl Carbonate, Alcohol Denat., Cyclohexasiloxane, Butylene Glycol, Silica, PEG-30 Dipolyhydroxystearate, Nylon-12, Glycerin, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Phenoxyethanol, Iron Oxides, Disteardimonium Hectorite, Triethoxycaprylylsilane, Panthenol, Tocopheryl Acetate, Glyceryl Stearate, Propanediol, Fragrance, Bisabolol, Disodium EDTA, Ethylhexylglycerin, PEG-8, Hydroxypropyl Cyclodextrin, Tocopherol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Sodium Benzoate, Ascorbic Acid, Citric Acid, Palmitoyl Tripeptide-38, Pentapeptide-34 Trifluoroacetate.

Questions or comments?

Call (862) 242-8129
Monday – Friday
(9 a.m. to 5 p.m. EST)
or visit www.isdin.com

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

ISDIN
PHOTO

Eryfotona®
Ageless

Ultralight Emulsion

BROAD SPECTRUM SPF 50

Designed for
Photoaging Defense

Tinted Sunscreen
with DNA Repairsomes™,
Q10, Peptide Complex
and Antioxidants

Water resistant
(40 minutes)

100% MINERAL
SUNSCREEN

3.4 FL OZ (100 mL)

INGREDIENTS AND APPEARANCE

ERYFOTONA AGELESS 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69494-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	107 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Lecithin, Soybean (UNII: 1DI56QDM62)
Disteardimonium Hectorite (UNII: X687XDK09L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Dibutyl Adipate (UNII: F4K100DXP3)
Butylene Glycol (UNII: 3XUS85K0RA)
Sodium Chloride (UNII: 451W47IQ8X)
Panthenol (UNII: WV9CM0O67Z)
Water (UNII: 059QF0KO0R)
Nylon-12 (UNII: 446U8J075B)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Ethylhexylglycerin (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Propanediol (UNII: 5965N8W85T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Tocopherol (UNII: R0ZB2556P8)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Alcohol (UNII: 3K9958V90M)
Denatonium Benzoate (UNII: 4YK5Z54AT2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Diethylhexyl Carbonate (UNII: YCD50O0Z6L)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Ferric Oxide Red (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Ferric Oxide Yellow (UNII: EX438O2MRT)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Phenoxyethanol (UNII: HIE492ZZ3T)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Palmitoyl Lysyldioxymethionyllysine (UNII: T7A529FB8O)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69494-003-01	1 in 1 CARTON	06/10/2019
1		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/10/2019

Labeler - ISDIN Corp. (079609155)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoris Feltor		464201441	MANUFACTURE(69494-003)