Home NDC 13630-0095 ALOE UP
Product NDC 13630-0095
11-digit product format 136300095
Labeler code 13630
Product ID 13630-0095_205c42c1-6830-4e70-e054-00144ff88e88
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 2015-07-27
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 25 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 13630-0095-4 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 13630-0095-4 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 13630-0095-4 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 13630-0095-4 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 13630-0095-4 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 13630-0095-4 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 13630-0095-4 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 13630-0095-4 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13630-0095-4 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 13630-0095-4 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 13630-0095-4 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 13630-0095-4 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 13630-0095-4 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 13630-0095-4 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 13630-0095-4 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 13630-0095-4 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 13630-0095-4 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 13630-0095-4 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 13630-0095-4 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 13630-0095-4 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 13630-0095-4 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 13630-0095-4 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13630-0095-4 ALOE UPBROAD SPECTRUM SPF 30 177 mL in 1 CAN SPRAY 177 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 DIBUTYL MALEATE INACTIVE INGREDIENT 4X371TMK9K ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 DIETHYLHEXYL 2,6-NAPHTHALATE INACTIVE INGREDIENT I0DQJ7YGXM ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13630-0095 ALOE UP BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 Legacy NDC, 1 package rows 20150923_205c42c1-682f-4e70-e054-00144ff88e88.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 13630-0095-4 13630009504 177 mL in 1 CAN 177 ml Historical