Home NDC 58443-0108-3 MAX BLOCK
Product NDC 58443-0108
Requested package NDC 58443-0108-3
11-digit product format 584430108
Labeler code 58443
Product ID 58443-0108_9c59f2e3-fc95-4ada-e053-2a95a90acbf4
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-01-31
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 74 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARBOMER 940 INACTIVE INGREDIENT 4Q93RCW27E MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MAX BLOCK SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0108-3 58443010803 118 mL in 1 BOTTLE (58443-0108-3) 118 ml 2013-01-31 0000-00-00 No No Current