FDA.reportPublic FDA data

Eryfotona Actinica Ultralight Emulsion

Manufacturer
ISDIN Corp
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:37:54

Label at a glance#

ProductEryfotona Actinica Ultralight Emulsion
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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:...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 11%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Diethylhexyl Carbonate, Dibutyl Adipate, Cyclopentasiloxane, Dicaprylyl Carbonate, Alcohol Denat., Cyclohexasiloxane, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Nylon-12, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Tocopheryl Acetate, Glyceryl Stearate, Fragrance, Bisabolol, Disodium EDTA, Ethylhexylglycerin, Panthenol, PEG-8, Tocopherol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid.

Questions or comments?

OTC - QUESTIONS SECTION

Call (862) 242-8129
Monday – Friday
(9 a.m. to 5 p.m. EST)
or visit www.isdin/us
USA Patent Pending

PRINCIPAL DISPLAY PANEL - 4 mL Tube Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISDIN
PHOTO

Eryfotona
Actinica®

Ultralight Emulsion

BROAD SPECTRUM SPF 50+

Designed for
Actinic Damage

100% MINERAL SUNSCREEN
WITH DNA REPAIRSOMES®

Water resistant
(40 minutes)

0.14 FL OZ (4 mL)

Principal Display Panel - 4 mL Tube Packet
Principal Display Panel - 4 mL Tube Packet

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69494-302-10Eryfotona Actinica Ultralight Emulsion1 in 1 CARTONEMULSION111
69494-302-10Eryfotona Actinica Ultralight Emulsion10 mL in 1 BOTTLE, PLASTICEMULSION1011
69494-302-11Eryfotona Actinica Ultralight Emulsion2 mL in 1 TUBEEMULSION211
69494-302-11Eryfotona Actinica Ultralight Emulsion12 in 1 CARTONEMULSION1211
69494-302-12Eryfotona Actinica Ultralight Emulsion1 in 1 CARTONEMULSION111
69494-302-12Eryfotona Actinica Ultralight Emulsion2 mL in 1 BOTTLE, PLASTICEMULSION211
69494-302-13Eryfotona Actinica Ultralight Emulsion1 in 1 CARTONEMULSION111
69494-302-13Eryfotona Actinica Ultralight Emulsion50 mL in 1 BOTTLE, PLASTICEMULSION5011
69494-302-14Eryfotona Actinica Ultralight Emulsion12 in 1 CARTONEMULSION1211
69494-302-14Eryfotona Actinica Ultralight Emulsion4 mL in 1 TUBEEMULSION411
69494-302-15Eryfotona Actinica Ultralight Emulsion4 mL in 1 TUBEEMULSION411
69494-302-15Eryfotona Actinica Ultralight Emulsion1 in 1 PACKETEMULSION111
69494-302-30Eryfotona Actinica Ultralight Emulsion1 in 1 CARTONEMULSION111
69494-302-30Eryfotona Actinica Ultralight Emulsion100 mL in 1 BOTTLE, PLASTICEMULSION10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69494-302ERYFOTONA ACTINICA ULTRALIGHT EMULSION (SUNSCREEN) EMULSION [ISDIN CORP]11Current NDC, Legacy NDC, 14 package rows20241121_1d4b88d3-bee9-102c-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
DIETHYLHEXYL CARBONATEINACTIVE INGREDIENTYCD50O0Z6L1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69494-30269494-302-30, 69494-302-10, 69494-302-12, 69494-302-13, 69494-302-14, 69494-302-11, 69494-302-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
SOYBEAN LECITHIN1DI56QDM62IACT
WATER059QF0KO0RIACT
DIETHYLHEXYL CARBONATEYCD50O0Z6LIACT
Dibutyl AdipateF4K100DXP3IACT
CYCLOMETHICONE 50THT5PCI0RIACT
Dicaprylyl Carbonate609A3V1SUAIACT
Alcohol3K9958V90MIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
CYCLOMETHICONE 6XHK3U310BAIACT
Butylene Glycol3XUS85K0RAIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
Nylon-12446U8J075BIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
Dimethicone92RU3N3Y1OIACT
Sodium Chloride451W47IQ8XIACT
PhenoxyethanolHIE492ZZ3TIACT
Disteardimonium HectoriteX687XDK09LIACT
TriethoxycaprylylsilaneLDC331P08EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LEVOMENOL24WE03BX2TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
Ethylhexylglycerin147D247K3PIACT
PanthenolWV9CM0O67ZIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TocopherolR0ZB2556P8IACT
Ascorbyl PalmitateQN83US2B0NIACT
Ascorbic AcidPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ANACYSTIS NIDULANSUV4FTL6UAWIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eryfotona Actinica Ultralight EmulsionSUNSCREENISDIN Corp1d4b88d3-bee9-102c-e054-00144ff8d46c2024-11-18WarningsExact identifier
ndc (package): 69494-302-12
ndc (package): 69494-302-11
ndc (package): 69494-302-15
ndc (package): 69494-302-10
ndc (package): 69494-302-30
ndc (package): 69494-302-13
ndc (package): 69494-302-14
ndc (product): 69494-302
ndc11 (package): 69494030211
ndc11 (package): 69494030213
ndc11 (package): 69494030210
ndc11 (package): 69494030215
ndc11 (package): 69494030230
ndc11 (package): 69494030214
ndc11 (package): 69494030212
spl id: a2e2bbf6-ebd4-4c22-bdf2-49652583d714
spl set id: 1d4b88d3-bee9-102c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.