Home NDC 54473-224-04 Affinia
Product NDC 54473-224
Requested package NDC 54473-224-04
11-digit product format 544730224
Labeler code 54473
Product ID 54473-224_f178d444-f5ee-1aa8-e053-2a95a90ab840
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form LOTION
Route TOPICAL
Labeler Melaleuca, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-08-01
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 2 g/120mL; g/120mL; g/120mL; g/120mL
NDC exclude flag No
Listing certified through 2024-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 54473-224-01 AffiniaFacial Moisturizer 120 mL in 1 BOTTLE, PUMP LOTION 120 6 54473-224-04 AffiniaFacial Moisturizer 1 in 1 BOX LOTION 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 HOMOSALATE ACTIVE MOIETY V06SV4M95S AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 OCTISALATE ACTIVE MOIETY 4X49Y0596W AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER INACTIVE INGREDIENT W59H9296ZG AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 CALCIUM PANTOTHENATE INACTIVE INGREDIENT 568ET80C3D AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 GLYCERYL STEARATE SE INACTIVE INGREDIENT FCZ5MH785I AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 MANGIFERA INDICA SEED BUTTER INACTIVE INGREDIENT 4OXD9M35X2 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 NIACINAMIDE INACTIVE INGREDIENT 25X51I8RD4 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 PHENOXYETHYL CAPRYLATE INACTIVE INGREDIENT GMI5AN7T8U AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 PYRIDOXINE HYDROCHLORIDE INACTIVE INGREDIENT 68Y4CF58BV AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 SHEANUT OIL INACTIVE INGREDIENT O88E196QRF AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 SODIUM ASCORBYL PHOSPHATE INACTIVE INGREDIENT 836SJG51DR AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 SODIUM STEAROYL GLUTAMATE INACTIVE INGREDIENT 65A9F4P024 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 TRISODIUM ETHYLENEDIAMINE DISUCCINATE INACTIVE INGREDIENT YA22H34H9Q AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-224 AFFINIA FACIAL MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MELALEUCA, INC.] 6 Legacy NDC, 2 package rows 20230106_97def817-8a7b-450d-acd3-74d2843bc92f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54473-224-04 54473022404 1 BOTTLE, PUMP in 1 BOX (54473-224-04) > 120 mL in 1 BOTTLE, PUMP (54473-224-01) 2018-01-01 0000-00-00 No No Current