Home NDC 13630-0096 Prebel
Product NDC 13630-0096
11-digit product format 136300096
Labeler code 13630
Product ID 13630-0096_9c5c91dc-89b6-63b4-e053-2a95a90ab9b3
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, oxybenzone and octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Prime Packaging Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-03-07
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 26 mg/mL; 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 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 13630-0096-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 13630-0096-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 13630-0096-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 13630-0096-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 13630-0096-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 13630-0096-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 13630-0096-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 13630-0096-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13630-0096-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 13630-0096-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 13630-0096-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 13630-0096-4 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 13630-0096-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 13630-0096-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 13630-0096-4 1332a3947898…d4bfe170f9cd…
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 13630-0096-4 PrebelNude Protect SPF 70 Sunscreen 177 mL in 1 CAN SPRAY 177 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 DIBUTYL MALEATE INACTIVE INGREDIENT 4X371TMK9K PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 DIETHYLHEXYL 2,6-NAPHTHALATE INACTIVE INGREDIENT I0DQJ7YGXM PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE 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 13630-0096 PREBEL NUDE PROTECT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.] 3 Legacy NDC, 1 package rows 20200118_205ca3c3-61ce-59e7-e054-00144ff88e88.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13630-0096-4 13630009604 177 mL in 1 CAN (13630-0096-4) 177 ml 2012-03-07 0000-00-00 No No Current