Phelityl Day SPF 15

Product NDC
57913-2832
11-digit product format
579132832
Labeler code
57913
Product ID
57913-2832_da2e1c4d-5fe1-66d2-e053-2a95a90a0166
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone and Octinoxate
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
Active strength
20 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct57913-2832IInactivated by FDA2026-10-21
excluded packagepackage57913-283257913-2832-9IInactivated by FDA2026-10-21

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct57913-2832IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57913-283257913-2832-9IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-03-14Phelityl Day SPF 15
2022-01-28Phelityl Day SPF 15
2020-08-04Phelityl Day SPF 15
2020-01-31Phelityl Day SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57913-2832-9Phelityl Day SPF 151 in 1 CARTONLOTION17
57913-2832-9Phelityl Day SPF 1590 mL in 1 JARLOTION907

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
AvobenzoneACTIVE MOIETYG63QQF2NOXPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
OctinoxateACTIVE MOIETY4Y5P7MUD51PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
AllantoinINACTIVE INGREDIENT344S277G0ZPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Asian GinsengINACTIVE INGREDIENTCUQ3A77YXIPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Ceteth-20INACTIVE INGREDIENTI835H2IHHXPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Chamaemelum Nobile FlowerINACTIVE INGREDIENTO2T154T6OGPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Coco GlucosideINACTIVE INGREDIENTICS790225BPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Emu OilINACTIVE INGREDIENT344821WD61PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3PPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B0PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Hydnocarpus Kurzii Seed OilINACTIVE INGREDIENTN757YEZ18QPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Myristyl AlcoholINACTIVE INGREDIENTV42034O9PUPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
O-Cymen-5-OlINACTIVE INGREDIENTH41B6Q1I9LPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Octyldodecyl NeopentanoateINACTIVE INGREDIENTX8725R883TPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999RPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Shea ButterINACTIVE INGREDIENTK49155WL9YPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Steareth-2INACTIVE INGREDIENTV56DFE46J5PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Steareth-20INACTIVE INGREDIENTL0Q8IK9E08PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
Tetrahexyldecyl AscorbateINACTIVE INGREDIENT9LBV3F07AZPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57913-2832PHELITYL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]7Legacy NDC, 2 package rows20241017_5e2347cb-4139-4bd8-af80-9f0a9aa0f12b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57913-2832-9579132832091 JAR in 1 CARTON (57913-2832-9) > 90 mL in 1 JAR1 jar2013-04-100000-00-00NoNoCurrent