Home NDC 58443-0200-4 Australian Gold
Product NDC 58443-0200
Requested package NDC 58443-0200-4
11-digit product format 584430200
Labeler code 58443
Product ID 58443-0200_9c590d56-67d9-bfdd-e053-2995a90a02f3
Type HUMAN OTC DRUG
Nonproprietary name homosalate, octinoxate, octisalate and titanium dioxide
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-11-02
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OCTINOXATE
Active strength 25 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 · 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 58443-0200-4 Australian GoldKids SPF 50 Sunscreen 237 mL in 1 BOTTLE LOTION 237 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HOMOSALATE ACTIVE INGREDIENT V06SV4M95S AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 CAPRYLHYDROXAMIC ACID INACTIVE INGREDIENT UPY805K99W AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 CARBOMER 940 INACTIVE INGREDIENT 4Q93RCW27E AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 KAKADU PLUM INACTIVE INGREDIENT 0ZQ1D2FDLI AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER INACTIVE INGREDIENT 39DK5WQ2PR AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 POLYHYDROXYSTEARIC ACID (2300 MW) INACTIVE INGREDIENT YXH47AOU0F AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0200 AUSTRALIAN GOLD KIDS SPF 50 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES INC.] 3 Legacy NDC, 1 package rows 20200118_23915bcf-1ca5-71a8-e054-00144ff8d46c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0200-4 58443020004 237 mL in 1 BOTTLE (58443-0200-4) 237 ml 2015-11-02 0000-00-00 No No Current