Home NDC 58892-348 CoTZ Face Prime and Protect SPF 40 (Non-Tinted)
Product NDC 58892-348
11-digit product format 588920348
Labeler code 58892
Product ID 58892-348_9498c109-3155-481c-a847-975cb655f6bc
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Fallien Cosmeceuticals, LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 80; 38 mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 58892-348 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-348 58892-348-45 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CoTZ Face Prime and Protect SPF 40 (Non-Tinted)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-348-45 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) 42.5 g in 1 TUBE CREAM 42.5 2 58892-348-45 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-348 COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 2 Current NDC, Legacy NDC, 2 package rows 20250112_f106f52b-2157-46c7-9f7c-50f43a649050.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 344 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Calico OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 96437795-906f-4e11-ac69-c0c2ae264aae 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cashew OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS b5527aba-5856-44cd-a1d5-f2d7cefb45ea 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 9b641ccb-3046-4b21-8164-b80813090cb4 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 2500fe73-00e2-47ba-9e2b-1c268ed4a9e6 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Bamboo OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 4df1b021-5028-456e-87f2-a96ea6c26c7b 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cedar OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 830a485c-53d4-4fa9-b0cd-0fd2a9bd234b 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 8a9fe755-32a2-49b0-8c78-f84bd2ba148f 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Honey OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS c5f3f1bc-adca-495f-b1bc-51c91d42a480 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Uber OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 64db3a1f-d6c7-4766-a52c-a4b0c39e2633 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Walnut OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 582a8244-dab8-4861-9115-2e895a586fb9 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Bronze OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 377405a6-b6c6-4afb-9270-73d933029054 2021-07-13 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Ivory OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 9f7c8d53-6549-4bac-bbae-a2b73fdf6b05 2021-07-12 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Beige OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 5a22b123-9077-4b8a-ac4c-1bdd475c6ac3 2021-07-12 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Calico OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 4647828c-661d-4ebe-b27e-13d8b89647b8 2021-07-12 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Honey OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS c82f36da-16ce-45f4-9786-2026a359060a 2021-07-12 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Wheat OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 3d86dca5-9e33-4284-a4c1-f5eed64b0620 2021-07-12 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Willow OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 0489a046-2173-4137-abff-c6a7cdb5e8fd 2021-07-12 Warnings Exact identifier application number: M020 H.E.B. Solutions Sunscreen SPORT SPF 70 LOTION H.E.B 00cade74-9a8f-4af9-a809-ebf0ff2bbc3c 2021-07-09 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen KIDS SPF 70 LOTION H.E.B 9f08c40e-b5c6-4ca4-8c24-0a0f98787217 2021-07-09 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 50 LOTION H.E.B 6e45677e-1066-498e-b423-109a94a152aa 2021-07-09 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 58892-348-45 58892034845 1 TUBE in 1 CARTON (58892-348-45) / 42.5 g in 1 TUBE 1 tube 2018-11-15 0000-00-00 No No Current