FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage71435-8202-6IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage71435-8202-6IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage71435-8202-6EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
IngredientStrength
AVOBENZONE30 mg/mL
OCTINOXATE73 mg/mL
OCTOCRYLENE30 mg/mL
OXYBENZONE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d557d554-5161-482c-bd78-7721c7dc9a6eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71435-8202-62021-12-02C16284748780-19d75b9d0-8b90-f424-e053-dadaa90a57ceMilani Prime Protect SPF 30 Face Primer
71435-8202-62020-01-31C16284748780-19d75b9d0-8b90-f424-e053-dadaa90a57ceMilani Prime Protect SPF 30 Face Primer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71435-8202-6Milani Prime Protect SPF 30 Face Primer30 mL in 1 TUBECREAM3011
71435-8202-6Milani Prime Protect SPF 30 Face Primer1 in 1 CARTONCREAM111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71435-8202MILANI PRIME PROTECT SPF 30 FACE PRIMER (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [THE MILANI GROUP, INC.]11Current NDC, Legacy NDC, 2 package rows20241207_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 139 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV Defense me. Matte Airy-Fit SunscreenZINC OXIDEMAGNIF CO., LTD459f2b8d-453c-4dee-e063-6394a90a45092025-12-10WarningsExact identifier
application number: M020
RoC Hydration Plus SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincare45a3e250-8195-344d-e063-6294a90ae6812025-12-10WarningsExact identifier
application number: M020
ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincarebf3c1474-e353-63a5-e053-2a95a90a9b262025-12-10WarningsExact identifier
application number: M020
ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincaref161d754-0c32-2fbe-e053-2a95a90a6b472025-12-10WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242ff053-b8c0-4f90-e063-6294a90a7bb32025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORYOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ef1f8-ad12-4f80-e063-6394a90a3e3c2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e810d366-0c32-5b1c-e053-2a95a90a622e2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242b7d0e-82d8-793c-e063-6294a90a4aa32025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.eb744367-f318-e1e2-e053-2a95a90a2cc42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242faaed-e85a-a1d7-e063-6294a90aea922025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247d6c0e-8f88-faf0-e063-6394a90a10da2025-12-09WarningsExact identifier
application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAekyung Industrial Co., Ltd.1e9a5c77-7027-3b52-e063-6394a90ac0eb2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e8241828-17b2-96c5-e053-2a95a90a12e52025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.1176181b-1331-ba68-e063-6394a90a961a2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247b56ad-4b61-8b6f-e063-6394a90af3b62025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247afcae-855e-3f69-e063-6394a90a42312025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.24306304-4d0d-c5f0-e063-6394a90afad52025-12-09WarningsExact identifier
application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACKOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAekyung Industrial Co., Ltd.1f9c7718-6fde-236c-e063-6394a90afa192025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3482855b-de85-a5a7-e063-6294a90a55ae2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e7e6-b301-136d-e063-6294a90aba182025-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71435-8202-6714358202061 TUBE in 1 CARTON (71435-8202-6) / 30 mL in 1 TUBE1 tube2017-11-250000-00-00NoNoCurrent