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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69494-30269494-302-10DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d4b88d3-bee9-102c-e054-00144ff8d46cAvailable on FDA.report

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZERYFOTONA ACTINICA ULTRALIGHT EMULSION (SUNSCREEN) EMULSION [ISDIN CORP]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZERYFOTONA ACTINICA ULTRALIGHT EMULSION (SUNSCREEN) EMULSION [ISDIN CORP]1
DIETHYLHEXYL CARBONATEINACTIVE INGREDIENTYCD50O0Z6LERYFOTONA ACTINICA ULTRALIGHT EMULSION (SUNSCREEN) EMULSION [ISDIN CORP]1

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

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 88 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION7d9c0f81-005f-4223-940e-a64143db52752026-01-06WarningsExact identifier
application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)31e976a2-0623-0dca-e063-6394a90a08da2026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)315a5ca4-4536-d585-e063-6294a90a1c502026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION51f759b7-8c49-41d4-aaa3-f901d599cac52026-01-06WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION463dc557-9743-4a38-969e-2c78fc10ee2a2026-01-06WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION23bb4225-bfb5-47e2-80fe-733761ba40692026-01-06WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONe881e637-e0f0-4c90-8343-2be6e74020b82026-01-06WarningsExact identifier
application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONd308d578-c881-4c10-8c79-9e3cd58b694c2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC051b7413-8f1b-7135-e063-6294a90a93642026-01-06WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Inc47bc6776-1130-0162-e063-6294a90a2adc2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsExact identifier
application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Love LetterAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD47d22c6d-49fd-f97c-e063-6294a90a6ba12026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ab90db-51bd-ffb3-e063-6294a90a852b2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ac28e7-41f1-bd4e-e063-6294a90a0e7b2026-01-06WarningsExact identifier
application number: M020
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
application number: M020

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