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 24 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLEL'Oreal USA Products Inc79fd34ad-cd4a-4fa0-9b7c-e0a2252654da2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLESICOS ET CIE3ff286c0-4515-4cab-9b93-a782545b2f362026-05-27WarningsExact identifier
application number: M020
MyDerm SPF 50HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Inspec Solutions LLC1a995cda-dc67-419c-90e6-c61050c760982026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc2b634b3f-0d2b-4ae4-b302-9befb14a90df2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEfce593a2-f4ed-46c1-81a1-be3941649e472026-05-27WarningsExact identifier
application number: M020
BROTEGE Good Boy Protection SPF 15 and Retinol Daily MoisturizerBENZOPHENONE-3, BUTYLE METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENESpa de Soleil1f47e508-58dd-fab4-e063-6394a90a668a2026-05-27WarningsExact identifier
application number: M020
GOONGBE Waterful SunLotion Mild SPF 40ZINC OXIDEZero to Seven Inc.1e86edfd-d089-ba41-e063-6294a90a67092026-05-27WarningsExact identifier
application number: M020
GOONGBE Baby Easy Wash SunLotion SPF 30ZINC OXIDEZero to Seven Inc.1e86c2a9-a5c3-95cb-e063-6394a90a014d2026-05-27WarningsExact identifier
application number: M020
Stream2Sea Reef Safer Mineral Sunscreen SPF40ZINC OXIDEStream2Sea, LLC52e73c23-75ec-d8a8-e063-6294a90a54932026-05-27WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDERiversol52b8f588-8383-634e-e063-6294a90a8f8b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDERiversol52b92725-6d9a-768a-e063-6394a90ac9332026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Jazzy BerryZINC OXIDEOdacite52b97fb0-84d6-a408-e063-6294a90a9be92026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - True NudeZINC OXIDEOdacite52b9be2a-4958-f537-e063-6294a90a7a1b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDESolesence, Inc.52ba09cb-edcc-a405-e063-6394a90a6aab2026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Bubble GumZINC OXIDEOdacite52b9fb0a-0554-0de2-e063-6294a90a09d32026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDESolesence, Inc.52ba07f1-b74e-a4b6-e063-6394a90a74732026-05-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 50 SunscreenZINC OXIDESKIN DAMAGE INC.52ba2f12-839f-cea1-e063-6394a90a5ae62026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Bronze JolieZINC OXIDEOdacite52ba360e-375c-0469-e063-6294a90a020e2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Golden HourZINC OXIDEOdacite52ba8e03-1944-b73d-e063-6294a90a50392026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Sienna RoseZINC OXIDEOdacite52ba7f12-2b79-79cf-e063-6294a90a92d82026-05-26WarningsExact 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