Home NDC 58443-0083-3 Australian Gold Hello Kitty
Product NDC 58443-0083
Requested package NDC 58443-0083-3
11-digit product format 584430083
Labeler code 58443
Product ID 58443-0083_9c595a16-9a3a-c009-e053-2a95a90a5867
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-12-23
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 45 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58443-0083-3 Australian Gold Hello KittyBROAD SPECTRUM SPF 45 88 mL in 1 BOTTLE LOTION 88 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ALUMINUM HYDRIDE INACTIVE INGREDIENT KZJ3T010RQ AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ARTEMISIA PRINCEPS LEAF OIL INACTIVE INGREDIENT F9S1101A2V AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 BUDDLEJA DAVIDII LEAF INACTIVE INGREDIENT X380815D32 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 7K68DGG29P AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CETEARETH-22 INACTIVE INGREDIENT 28VZG1E234 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 DIBUTYL ADIPATE INACTIVE INGREDIENT F4K100DXP3 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 HEXYL LAURATE INACTIVE INGREDIENT 4CG9F9W01Q AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLCELLULOSE (100 CPS) INACTIVE INGREDIENT 4GFU244C4J AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PEG-12 DIMETHICONE (300 CST) INACTIVE INGREDIENT ZEL54N6W95 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYGLYCERYL-3 DISTEARATE INACTIVE INGREDIENT ZI1LK470XV AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) INACTIVE INGREDIENT 25LXE464L2 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0083 AUSTRALIAN GOLD HELLO KITTY BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 3 Legacy NDC, 1 package rows 20200118_38628d1f-22eb-41a2-b94f-7d9601189f07.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0083-3 58443008303 88 mL in 1 BOTTLE (58443-0083-3) 88 ml 2013-12-23 0000-00-00 No No Current