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 129 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Canopy SPF 40 Tinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 358319c5-ae35-cb3b-e063-6394a90ad77f 2025-12-12 Exact identifier application number: M020 Non-Tinted Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581ab49-ef55-3743-e063-6394a90a3bd5 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581cf33-3520-42f7-e063-6394a90a6f93 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 358248e6-16cf-6f9b-e063-6394a90a55d7 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 35828e76-66db-49de-e063-6294a90a2b99 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3592b2c7-295a-7c60-e063-6394a90a387b 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 3592fd5f-13d1-9aec-e063-6394a90abd67 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 359371f2-2407-e1a1-e063-6294a90a2165 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397fc3c9-9d30-adcf-e063-6394a90ac761 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39800bf1-e01a-e1c8-e063-6294a90a53bf 2025-12-12 Exact identifier application number: M020 Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397130ea-dfad-ecd3-e063-6394a90a7da4 2025-12-12 Exact identifier application number: M020 Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39716532-a699-63b7-e063-6294a90aa0f0 2025-12-12 Exact identifier application number: M020 Sun Elegant Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE SKIN BY NESRIN 3580ae10-1867-cb68-e063-6394a90a72df 2025-12-12 Exact identifier application number: M020 Simply Zinc Mineral Sunscreen Tinted ZINC OXIDE SKIN BY NESRIN 3580da4f-116d-8108-e063-6294a90a7bf4 2025-12-12 Exact identifier application number: M020 PROTECTOR SOLAR NON-TINTED SPF SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE The Beez Kneez Skin Care & Acne Clinic LLC 358195c0-6d28-1ffe-e063-6394a90a6027 2025-12-12 Exact identifier application number: M020 PROTECTOR SOLAR TINTED SPF SUNSCREEN ZINC OXIDE The Beez Kneez Skin Care & Acne Clinic LLC 3581d973-ac0b-7d2e-e063-6294a90ae2b3 2025-12-12 Exact identifier application number: M020 Matte Velvet Tint TITANIUM DIOXIDE, ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 3583f860-664b-2658-e063-6394a90a3857 2025-12-12 Exact identifier application number: M020 Satin Tint ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 35920108-7f8a-27d4-e063-6294a90a0ef6 2025-12-12 Exact identifier application number: M020 SPF Lip TITANIUM DIOXIDE, ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 359297cd-10e2-6ddd-e063-6394a90a4aa0 2025-12-12 Exact identifier application number: M020 Matte Velvet Tint TITANIUM DIOXIDE, ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 359641c5-0e19-f243-e063-6394a90aeebc 2025-12-12 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