ALOE UP

Product NDC
13630-0093
11-digit product format
136300093
Labeler code
13630
Product ID
13630-0093_9c5be075-dee3-3468-e053-2995a90a6ce6
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate and octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-25
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
24 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct13630-0093DDiscontinued by firm2026-10-05
excluded packagepackage13630-009313630-0093-4DDiscontinued by firm2026-10-05

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 · 24 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 packagepackage13630-0093-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13630-0093-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13630-0093-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13630-0093-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13630-0093-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13630-0093-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13630-0093-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13630-0093-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13630-0093-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13630-0093-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13630-0093-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13630-0093-4557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
DIBUTYL MALEATEINACTIVE INGREDIENT4X371TMK9KALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PALOE UP BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0093-413630009304177 mL in 1 CAN (13630-0093-4) 177 ml2015-08-250000-00-00NoNoCurrent