R.E.M. Day SPF 30

Product NDC
57913-2834
11-digit product format
579132834
Labeler code
57913
Product ID
57913-2834_6734af15-1a64-4b4b-a8f3-d707d871511f
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, and Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Erno Laszlo, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-10
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE
Active strength
30 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57913-2834IInactivated by FDA2026-10-05
excluded packagepackage57913-283457913-2834-9IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57913-2834-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57913-2834-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57913-2834-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57913-2834-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57913-2834-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57913-2834-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57913-2834-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57913-2834-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57913-2834-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57913-2834-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57913-2834-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57913-2834-9557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57913-2834-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57913-2834-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57913-2834-91332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57913-2834-9fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57913-2834-986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57913-2834-9bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57913-2834-98dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57913-2834-9e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57913-2834-99bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57913-2834-92020-01-31C16284748780-19d75b9d0-c010-f424-e053-dadaa90a57ceR.E.M. Day SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57913-2834-9R.E.M. Day SPF 3090 mL in 1 BOTTLELOTION901
57913-2834-9R.E.M. Day SPF 301 in 1 CARTONLOTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
OctisalateACTIVE INGREDIENT4X49Y0596WR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
AvobenzoneACTIVE MOIETYG63QQF2NOXR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
OctinoxateACTIVE MOIETY4Y5P7MUD51R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
OctisalateACTIVE MOIETY4X49Y0596WR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Asian GinsengINACTIVE INGREDIENTCUQ3A77YXIR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Avocado OilINACTIVE INGREDIENT6VNO72PFC1R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Centella AsiaticaINACTIVE INGREDIENT7M867G6T1UR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Echinacea PurpureaINACTIVE INGREDIENTQI7G114Y98R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3PR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
European Hazelnut OilINACTIVE INGREDIENT8RQ2839AVGR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
GinkgoINACTIVE INGREDIENT19FUJ2C58TR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Hyaluronate SodiumINACTIVE INGREDIENTYSE9PPT4THR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Hydnocarpus Kurzii Seed OilINACTIVE INGREDIENTN757YEZ18QR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Jojoba OilINACTIVE INGREDIENT724GKU717MR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
LevomenolINACTIVE INGREDIENT24WE03BX2TR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
O-Cymen-5-OlINACTIVE INGREDIENTH41B6Q1I9LR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Octyldodecyl NeopentanoateINACTIVE INGREDIENTX8725R883TR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999RR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Sesame OilINACTIVE INGREDIENTQX10HYY4QVR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Sodium Pyrrolidone CarboxylateINACTIVE INGREDIENT469OTG57A2R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Steareth-20INACTIVE INGREDIENTL0Q8IK9E08R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Sunflower OilINACTIVE INGREDIENT3W1JG795YIR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Tetrahexyldecyl AscorbateINACTIVE INGREDIENT9LBV3F07AZR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVCR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2VR.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57913-2834R.E.M. DAY SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1Legacy NDC, 2 package rows20130426_2a7dfdf8-ed0d-4d30-93e1-b88c1a3de75c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57913-2834-95791328340990 mL in 1 BOTTLE90 mlHistorical