Eryfotona Actinica Mineral

Eryfotona Actinica Mineral by

Drug Labeling and Warnings

Eryfotona Actinica 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 ACTINICA 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 Actinica 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 sweat- ing.
  • 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, Propylene Glycol Dicaprylate/Dicaprate, Di- methicone, C15-19 Alkane, Dicaprylyl Carbonate, Silica, Dibutyl Adipate, PEG-30 Dipolyhydroxystearate, VP/Ei- cosene Copolymer, Polyglyceryl-2 Dipolyhydroxystea- rate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Magnesium Sulfate, 1,2-Hexanediol, Benzylidene Dime- thoxydimethylindanone, Caprylyl Glycol, Panthenol, Disteardimonium Hectorite, Tocopheryl Acetate, Di- methicone/Vinyl Dimethicone Crosspolymer, Iron Oxides, Fragrance, Propylene Carbonate, PEG-10 Dimethicone, PEG-8, Tocopherol, Phenoxyethanol, Lecithin, Plankton Extract, Triethoxycaprylylsilane, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid.

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
Actinica
Mineral

BROAD SPECTRUM SUNSCREEN SPF 50

Actinic Damage

DNA Repairsomes®
and Vitamin E
to help skin fight photoaging

3.4 FL OZ (100 mL)

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
ERYFOTONA ACTINICA MINERAL 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69494-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide189.16 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Dibutyl Adipate (UNII: F4K100DXP3)  
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)  
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
Dimethicone (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Tocopherol (UNII: R0ZB2556P8)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Ferric Oxide Red (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69494-006-011 in 1 CARTON09/01/202201/01/2023
1100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/01/202201/01/2023
Labeler - ISDIN Corp. (079609155)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoris Feltor464201441MANUFACTURE(69494-006)

Revised: 2/2023
Document Id: 44289b81-ee1d-4470-a138-3e7ac562c024
Set id: 1017721f-711d-43c8-a0ed-eba687e76f0f
Version: 3
Effective Time: 20230217
 
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