Home NDC 68634-050 Sheltered Broad Spectrum SPF 55 Sunscreen
Product NDC 68634-050
11-digit product format 686340050
Labeler code 68634
Product ID 68634-050_8cc522b4-c4f9-40f6-b24c-f58ea9eb8b0c
Type HUMAN OTC DRUG
Nonproprietary name homosalate, oxybenzone, octisalate, avobenzone, octocrylene
Dosage form LIQUID
Route TOPICAL
Labeler AMCOL Health & Beauty Solutions, Inc. DBA
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-09-01
Marketing end 0000-00-00
Substance HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 100 g/mL; g/mL; g/mL; g/mL; g/mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 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 68634-050-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68634-050-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68634-050-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68634-050-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68634-050-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68634-050-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68634-050-01 9bebd1f3094a…5416666fcb17…
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 68634-050-01 Sheltered Broad Spectrum SPF 55 Sunscreen 1 in 1 CARTON LIQUID 1 1 68634-050-01 Sheltered Broad Spectrum SPF 55 Sunscreen 50 mL in 1 BOTTLE LIQUID 50 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded avobenzone ACTIVE INGREDIENT G63QQF2NOX SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 homosalate ACTIVE INGREDIENT V06SV4M95S SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 octisalate ACTIVE INGREDIENT 4X49Y0596W SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 octocrylene ACTIVE INGREDIENT 5A68WGF6WM SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 avobenzone ACTIVE MOIETY G63QQF2NOX SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 homosalate ACTIVE MOIETY V06SV4M95S SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 octisalate ACTIVE MOIETY 4X49Y0596W SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 octocrylene ACTIVE MOIETY 5A68WGF6WM SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 oxybenzone ACTIVE MOIETY 95OOS7VE0Y SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 .alpha.-tocopherol acetate, DL- INACTIVE INGREDIENT WR1WPI7EW8 SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 bentonite INACTIVE INGREDIENT A3N5ZCN45C SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 butylene glycol INACTIVE INGREDIENT 3XUS85K0RA SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 carbomer copolymer type A INACTIVE INGREDIENT 71DD5V995L SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 chlorphenesin INACTIVE INGREDIENT I670DAL4SZ SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 dimethicone INACTIVE INGREDIENT 92RU3N3Y1O SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 ethylhexylglycerin INACTIVE INGREDIENT 147D247K3P SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 high density polyethylene INACTIVE INGREDIENT UG00KM4WR7 SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 kaolin INACTIVE INGREDIENT 24H4NWX5CO SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 picea abies wood INACTIVE INGREDIENT 72GZ8K8996 SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 sodium ascorbyl phosphate INACTIVE INGREDIENT 836SJG51DR SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 sodium polyacrylate (8000 mw) INACTIVE INGREDIENT 285CYO341L SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 tocopherol INACTIVE INGREDIENT R0ZB2556P8 SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 vitamin a palmitate INACTIVE INGREDIENT 1D1K0N0VVC SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 water INACTIVE INGREDIENT 059QF0KO0R SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68634-050 SHELTERED BROAD SPECTRUM SPF 55 SUNSCREEN (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA] 1 Legacy NDC, 2 package rows 20150909_c8d1be79-a585-4e04-ade2-4ee6d8e962a6.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68634-050-01 68634005001 1 in 1 CARTON Historical