Home NDC 71435-8202 Milani Prime Protect SPF 30 Face Primer
Product NDC 71435-8202
11-digit product format 714358202
Labeler code 71435
Product ID 71435-8202_2874ab15-80ca-c108-e063-6294a90a43a0
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octinoxate, Octocrylene, and Oxybenzone
Dosage form CREAM
Route TOPICAL
Labeler The Milani Group, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-11-25
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Active strength 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 · 6 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 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 71435-8202-6 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 71435-8202-6 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 71435-8202-6 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Milani Prime Protect SPF 30 Face Primer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL OCTINOXATE 73 mg/mL OCTOCRYLENE 30 mg/mL OXYBENZONE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 71435-8202-6 Milani Prime Protect SPF 30 Face Primer 30 mL in 1 TUBE CREAM 30 11 71435-8202-6 Milani Prime Protect SPF 30 Face Primer 1 in 1 CARTON CREAM 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71435-8202 MILANI PRIME PROTECT SPF 30 FACE PRIMER (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [THE MILANI GROUP, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20241207_d557d554-5161-482c-bd78-7721c7dc9a6e.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 135 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db5721-2b32-d4d8-e063-6294a90a47d7 2025-12-11 Exact identifier application number: M020 SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db14e1-f995-b649-e063-6294a90afd69 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D. 351ce033-6bd0-574e-e063-6394a90af448 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D., 351c9727-d7ac-9c3f-e063-6294a90a7721 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c0c1e-5712-1e23-e063-6394a90abe6f 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351d27e3-00d4-8d31-e063-6394a90aaf72 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351db99e-262f-b67e-e063-6394a90a3418 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection NT ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c5f6f-86e6-7219-e063-6294a90a3745 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE DAISY'S SKIN TRANSFORMATION LLC 37d9fbf5-d602-d3dc-e063-6394a90abe53 2025-12-11 Exact identifier application number: M020 Tinted Mineral 40 TITANIUM DIOXIDE, ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374d53a7-be0b-4d7a-e063-6394a90a37c4 2025-12-11 Exact identifier application number: M020 Daily Protection 40 ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374d9c77-ed9f-a518-e063-6394a90a34fa 2025-12-11 Exact identifier application number: M020 Tinted Mineral 40 TITANIUM DIOXIDE, ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374df66d-eb9b-c4a7-e063-6394a90a3cc6 2025-12-11 Exact identifier application number: M020 Daily Protection 40 ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374e2294-7281-c7b9-e063-6394a90acc89 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Mineral Protection TITANIUM DIOXIDE, ZINC OXIDE CAPE COD SKIN CARE CO. INC. 387f6dd5-3901-0849-e063-6294a90af8bc 2025-12-11 Exact identifier application number: M020 Non - Tinted Mineral Sunscreen ZINC OXIDE NEXTEX CORPORATION 35bacfcf-0254-aa0a-e063-6394a90a1475 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LEDUC, XUANTO MD 387e2e59-c5db-c70e-e063-6394a90a2d26 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Mineral Protection TITANIUM DIOXIDE, ZINC OXIDE CAPE COD SKIN CARE CO. INC. 390779a8-4556-27a5-e063-6294a90a1200 2025-12-11 Exact identifier application number: M020 non-tinted sheer matte mineral TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35ba6cc9-0d49-6d0c-e063-6394a90ac7c3 2025-12-11 Exact identifier application number: M020 sheer tinted matte mineral TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35ba9ca7-fe5c-9824-e063-6394a90a5c46 2025-12-11 Exact identifier application number: M020 illuminating mineral mousse TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35bb4d67-373f-f60c-e063-6394a90a974d 2025-12-11 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 71435-8202-6 71435820206 1 TUBE in 1 CARTON (71435-8202-6) / 30 mL in 1 TUBE 1 tube 2017-11-25 0000-00-00 No No Current