FDA.reportPublic FDA data

Eryfotona Actinica Ultralight Emulsion

Product NDC
69494-302
11-digit product format
694940302
Labeler code
69494
Product ID
69494-302_a2e2bbf6-ebd4-4c22-bdf2-49652583d714
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen
Dosage form
EMULSION
Route
TOPICAL
Labeler
ISDIN Corp
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-17
Substance
ZINC OXIDE
Active strength
11 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eryfotona Actinica Ultralight Emulsion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE11 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69494-302-106949403021010 g in 1 BOTTLE (69494-302-10) 10 g2016-02-240000-00-00NoNoCurrent
69494-302-116949403021112 TUBE in 1 CARTON (69494-302-11) / 2 mL in 1 TUBE12 tube2023-12-18NoNoCurrent
69494-302-12694940302121 BOTTLE, PLASTIC in 1 CARTON (69494-302-12) / 2 mL in 1 BOTTLE, PLASTIC2019-11-010000-00-00YesNoCurrent
69494-302-13694940302131 BOTTLE, PLASTIC in 1 CARTON (69494-302-13) / 50 mL in 1 BOTTLE, PLASTIC2023-05-01NoNoCurrent
69494-302-146949403021412 TUBE in 1 CARTON (69494-302-14) / 4 mL in 1 TUBE12 tube2023-10-30NoNoCurrent
69494-302-15694940302151 TUBE in 1 PACKET (69494-302-15) / 4 mL in 1 TUBE1 tube2024-07-01NoNoCurrent
69494-302-30694940302301 BOTTLE, PLASTIC in 1 CARTON (69494-302-30) / 100 mL in 1 BOTTLE, PLASTIC2019-11-010000-00-00NoNoCurrent