Home NDC 54473-164 Sun Shades
Product NDC 54473-164
11-digit product format 544730164
Labeler code 54473
Product ID 54473-164_14c560f4-08f8-4f3a-9eed-3014820bfd78
Type HUMAN OTC DRUG
Nonproprietary name Octisalate and Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Melaleuca, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2009-05-01
Marketing end 0000-00-00
Substance OCTISALATE; ZINC OXIDE
Active strength 9 g/177mL; g/177mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 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 54473-164-06 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 54473-164-06 110d247fa046…a55b01930146…
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 54473-164-06 Sun ShadesMineral Plus Sunscreen 177 mL in 1 TUBE CREAM 177 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTISALATE ACTIVE INGREDIENT 4X49Y0596W SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 ZINC ACTIVE MOIETY J41CSQ7QDS SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 BIXA ORELLANA SEED INACTIVE INGREDIENT O87354RZ5A SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 CETYL ETHYLHEXANOATE INACTIVE INGREDIENT 134647WMX4 SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 DICAPRYLYL CARBONATE INACTIVE INGREDIENT 609A3V1SUA SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 DIHEXADECYL PHOSPHATE INACTIVE INGREDIENT 2V6E5WN99N SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 ISOSTEARIC ACID INACTIVE INGREDIENT X33R8U0062 SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 KUKUI NUT OIL INACTIVE INGREDIENT TP11QR7B8R SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 LEVOMENOL INACTIVE INGREDIENT 24WE03BX2T SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 MACADAMIA OIL INACTIVE INGREDIENT 515610SU8C SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 NEOPENTYL GLYCOL DIHEPTANOATE INACTIVE INGREDIENT 5LKW3C543X SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 PENTYLENE GLYCOL INACTIVE INGREDIENT 50C1307PZG SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 POLYHYDROXYSTEARIC ACID (2300 MW) INACTIVE INGREDIENT YXH47AOU0F SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-164 SUN SHADES MINERAL PLUS SUNSCREEN (OCTISALATE AND ZINC OXIDE) CREAM [MELALEUCA, INC.] 1 Legacy NDC, 1 package rows 20110316_6b4d59e2-04f5-4a37-a8fd-062b1dca0794.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 54473-164-06 54473016406 177 mL in 1 TUBE 177 ml Historical