ALOE UP SUNSCREEN

Product NDC
61477-213
Requested package NDC
61477-213-14
11-digit product format
614770213
Labeler code
61477
Product ID
61477-213_dc949d17-dad2-8ac7-e053-2995a90ad4c5
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Aloe Care International, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-24
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61477-21361477-213-14DDiscontinued by firm2026-10-12

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
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61477-21361477-213-14IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61477-21361477-213-14IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
HOMOSALATEACTIVE INGREDIENTV06SV4M95SALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
HOMOSALATEACTIVE MOIETYV06SV4M95SALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
OCTISALATEACTIVE MOIETY4X49Y0596WALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
ALLANTOININACTIVE INGREDIENT344S277G0ZALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
CAMELLIA SINENSIS WHOLEINACTIVE INGREDIENTC5M4585ZBZALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XCALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9QALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61477-213ALOE UP SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) LOTION [ALOE CARE INTERNATIONAL, LLC]6Legacy NDC20240214_00e86762-db83-4c3a-9ce7-7b3f2ab0b3bd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61477-213-1461477021314118 mL in 1 TUBE (61477-213-14) 118 ml2014-02-240000-00-00NoNoCurrent