Eryfotona Ageless Tinted Mineral

Eryfotona Ageless Tinted Mineral by

Drug Labeling and Warnings

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

Drug Details [pdf]

ERYFOTONA AGELESS TINTED MINERAL- titanium dioxide lotion 
ISDIN Corp.

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.

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Eryfotona Ageless Tinted Mineral

Drug Facts

Active ingredient

Titanium Dioxide 17%

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.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• 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

Propylene Glycol Dicaprylate/Dicaprate, Water, Dimethicone, C15-19 Alkane, Dicaprylyl Carbonate, Silica, Dibutyl Adipate, PEG-30 Dipolyhydroxystearate, VP/Eicosene Copolymer, Polyglyceryl-2 Dipolyhydroxystearate, Iron Oxides, Caprylic/Capric Triglyceride, Glycerin, Butyloctyl Salicylate, Magnesium Sulfate, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Panthenol, Disteardimonium Hectorite, Tocopheryl Acetate, Propanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance, Propylene Carbonate, PEG-10 Dimethicone, Tetrasodium Glutamate Diacetate, Triethoxycaprylylsilane, PEG-8, Carbomer, Tocopherol, Polysorbate 20, Sodium Lactate, Phenoxyethanol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Sodium Benzoate, Ascorbic Acid, Citric Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, 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
Tinted Mineral

BROAD SPECTRUM SUNSCREEN SPF 50

Photoaging Defense

DNA Repairsomes®
Peptide Blend
and Antioxidants
to help skin fight photoaging

3.4 FL OZ (100 mL)

ERYFOTONA AGELESS TINTED MINERAL 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69494-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	192.39 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)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
Panthenol (UNII: WV9CM0O67Z)
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Sodium Lactate (UNII: TU7HW0W0QT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)
Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)
Propanediol (UNII: 5965N8W85T)
Pentapeptide-34 Trifluoroacetate (UNII: SQS1FA1FGW)
Tocopherol (UNII: R0ZB2556P8)
Ascorbyl Palmitate (UNII: QN83US2B0N)
1,2-Hexanediol (UNII: TR046Y3K1G)
Caprylyl Glycol (UNII: 00YIU5438U)
Polysorbate 20 (UNII: 7T1F30V5YH)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Ferric Oxide Red (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Phenoxyethanol (UNII: HIE492ZZ3T)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Propylene Carbonate (UNII: 8D08K3S51E)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ANACYSTIS NIDULANS (UNII: UV4FTL6UAW)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)
C15-19 Alkane (UNII: CI87N1IM01)
Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69494-007-01	1 in 1 CARTON	09/01/2022	01/01/2023
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	09/01/2022	01/01/2023

Labeler - ISDIN Corp. (079609155)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoris Feltor		464201441	MANUFACTURE(69494-007)

Revised: 2/2023

Document Id: 9abd28c8-ceeb-420b-9be7-d32c59163997

34390-5

Set id: a847e5b5-9fde-4cc0-a2e6-2f7d06ae96f3

Version: 3

Effective Time: 20230217