ALOE UP

Product NDC
13630-0093
Requested package NDC
13630-0093-4
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
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 · 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.

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