Home NDC 61354-085 Cream
Product NDC 61354-085
11-digit product format 613540085
Labeler code 61354
Product ID 61354-085_e776d7ee-d30e-e3dd-e053-2995a90a8cfa
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-30
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 5 mg/100mg; mg/100mg
NDC exclude flag No
Listing certified through 2023-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61354-085-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61354-085-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61354-085-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61354-085-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61354-085-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61354-085-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61354-085-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61354-085-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61354-085-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 61354-085-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-085-01 Cream 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-085 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e776de6a-f82d-73c9-e053-2a95a90a09a6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 72 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sky and Sol Face and Body Sunscreen Spf 30 ZINC OXIDE Delta Ecommerce LLC 47dbcf07-7e3a-e3de-e063-6294a90a2c21 2026-01-21 Warnings Exact identifier application number: M020 sunscreen TITANIUM DIOXIDE Guangdong Zhoubang Biotechnology Co., Ltd 48f13b1c-8104-881b-e063-6394a90a816d 2026-01-21 Warnings Exact identifier application number: M020 Sunscreen lip balm ETHYLHEXYL SALICYLATE Guangdong Zhoubang Biotechnology Co., Ltd 48f1ee5c-33d0-818c-e063-6294a90a1e59 2026-01-21 Warnings Exact identifier application number: M020 Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Mother CEILE SPF 30 PRIME PROTECT RADIATE MOTHER LE COSMETICS INC 490db6ef-d7f2-446c-e063-6294a90af303 2026-01-21 Warnings Exact identifier application number: M020 DewyVita Zero Spot Sunscreen OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE BAREUNPLAN CO.,LTD. 497c98c3-d809-52e0-e063-6294a90acca2 2026-01-21 Warnings Exact identifier application number: M020 Mario Badescu The Moisture Magnet SPF 15 OCTINOXATE, OXYBENZONE, AVOBENZONE Bentley Laboratories LLC 4c0b4733-96ea-4b1d-8a7b-13af66cc28d0 2026-01-21 Warnings Exact identifier application number: M020 Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE RV Skincare LLC 86b46c9b-6573-439b-b38b-2d76d495df6d 2026-01-20 Warnings Exact identifier application number: M020 Perfectif Even Skin Tone Cream Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE RV Skincare LLC 1b8cf189-0d06-4e86-bd7b-b77a638f1670 2026-01-20 Warnings Exact identifier application number: M020 Bella s Friends SPF50 Sunscreen ZINC OXIDE PANERGYTEKUSAINC 48ce4ef7-e24a-4894-e063-6294a90a49c8 2026-01-20 Warnings Exact identifier application number: M020 Christian Dior Invisible UV Fluid with Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Parfums Christian Dior 93a27f09-14e2-47a0-ac5f-4d3425e31ec9 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten ZINC OXIDE Clean Beauty For All, Inc (dba Saie) d00b978d-1682-4cde-ae5f-189e677136c4 2026-01-20 Warnings Exact identifier application number: M020 Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer ZINC OXIDE Clean Beauty For All, Inc b6bfd636-2f46-3fca-e053-2a95a90a05a6 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 19230647-29a3-d209-e063-6394a90aae36 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 8e2a2046-13e6-4a40-a0bc-65c979c59b93 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight ZINC OXIDE Clean Beauty For All, Inc (dba Saie) dbc4242a-3651-48be-bfc6-c595be5a2a15 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922f11d-10ce-82b4-e063-6394a90a6650 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922e001-e699-7ac5-e063-6394a90a25d9 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six ZINC OXIDE Clean Beauty For All, Inc (dba Saie) a9350360-7932-459f-806c-399fa265e6c0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1923067f-1ab9-d168-e063-6394a90adbd0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922ee84-d7d0-80b1-e063-6394a90acf7b 2026-01-20 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61354-085-01 61354008501 1 TUBE in 1 CARTON (61354-085-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current