Aloe Up

Product NDC
13630-0041
Requested package NDC
13630-0041-4
11-digit product format
136300041
Labeler code
13630
Product ID
13630-0041_9c5be075-dee2-3468-e053-2995a90a6ce6
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Oxybenzone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-01-05
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE
Active strength
17 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 packagepackage13630-004113630-0041-4IInactivated 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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0041-42023-01-30C16284748780-1f386c649-a8e6-0266-e053-dadaa90a7c1a059a2cf8-924a-44bb-bdf6-0525bb69f49d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0041-4Aloe UpDark Tanning Oil SPF 4177 mL in 1 CANSPRAY1773

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0041ALOE UP DARK TANNING OIL SPF 4 (OCTINOXATE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]3Legacy NDC, 1 package rows20200118_059a2cf8-924a-44bb-bdf6-0525bb69f49d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0041-413630004104177 mL in 1 CAN (13630-0041-4) 177 ml2009-01-050000-00-00NoNoCurrent