Home NDC 58443-0094-4 Baby Blanket
Product NDC 58443-0094
Requested package NDC 58443-0094-4
11-digit product format 584430094
Labeler code 58443
Product ID 58443-0094_9c595a16-9a48-c009-e053-2a95a90a5867
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-01-07
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength 77 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 · 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 BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PEG-30 DIPOLYHYDROXYSTEARATE INACTIVE INGREDIENT 9713Q0S7FO BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYQUATERNIUM-37 (10000 MPA.S) INACTIVE INGREDIENT 41QWS48DFN BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PPG-1 TRIDECETH-6 INACTIVE INGREDIENT 1K7417JX6Q BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BABY BLANKET BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) 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 58443-0094-4 58443009404 177 mL in 1 BOTTLE (58443-0094-4) 177 ml 2013-01-07 0000-00-00 No No Current