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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d557d554-5161-482c-bd78-7721c7dc9a6e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71435-8202-6	2021-12-02	C162847	48780-1	9d75b9d0-8b90-f424-e053-dadaa90a57ce	Milani Prime Protect SPF 30 Face Primer
71435-8202-6	2020-01-31	C162847	48780-1	9d75b9d0-8b90-f424-e053-dadaa90a57ce	Milani Prime Protect SPF 30 Face Primer

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 107 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e686a22f-bddc-5d7c-e053-2995a90a7b28	2025-12-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	090904d1-c04c-3fca-e063-6294a90a7cc7	2025-12-18	Warnings	Exact identifier application number: M020
Bye Bye Foundation Full Coverage Moisturizer SPF 50 Fair	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b098aba3-dad6-4421-a943-e88ce5e2f8d6	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep Mocha	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b3260833-8b7c-4d88-a55a-8cef4938442d	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral Rich	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	0a647c9a-2c71-4cd2-9503-e9ab96b857ee	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeep	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f246553e-17c2-4dba-855b-1942646bb834	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep Bronze	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	15de58a4-e2bc-425b-b50b-df2d87dd3bb4	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMedium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f493c3ea-41b3-4625-84a6-fab545a76940	2025-12-18	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	472f34c5-cefe-4884-9475-fd0666c925ac	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Broad Spectrum Sunscreen SPF 30	OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	d7238996-374b-07aa-e053-2995a90ae889	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Hyaluronic plus Peptide 24 Hydrating Moisturizer with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	eadacdae-3901-3f7c-e053-2a95a90ab184	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30	OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	f6801575-6081-7566-e053-2995a90a20a8	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	00280745-908b-468f-e063-6294a90aa12f	2025-12-18	Warnings	Exact identifier application number: M020
OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte Finish	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	10bd41ac-9b96-840d-e063-6394a90a98d9	2025-12-18	Warnings	Exact identifier application number: M020
Olay Glow plus Protect Sunscreen Dewy Glow SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	The Procter & Gamble Manufacturing Company	10bc4127-7569-d0de-e063-6294a90a97bf	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	29645d90-a444-4090-e063-6294a90ac7e3	2025-12-18	Warnings	Exact identifier application number: M020
Skin On Skin BC Foundation SPF 40 - Tan Golden	OCTISALATE, HOMOSALATE, ZINC OXIDE	YENSA Beauty, LLC	46440bac-de69-e59c-e063-6394a90a76c0	2025-12-18	Warnings	Exact identifier application number: M020
FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen	ZINC OXIDE	DONG WHA PHARM. CO., LTD.	46457c78-74d6-ea6a-e063-6294a90a24ac	2025-12-18	Warnings	Exact identifier application number: M020
THE MUG GUARD Invisible Gel Suncare for Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	4646988c-1060-ed5f-e063-6394a90aa765	2025-12-18	Warnings	Exact identifier application number: M020
Sage and Zinc Facial Hydrating SPF15	ZINC OXIDE	Emeis Cosmetics Pty Ltd	ccabd647-ecdd-7230-e053-2a95a90a7a96	2025-12-18	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Milani Prime Protect SPF 30 Face Primer	The Milani Group, Inc.	2024-12-04	HUMAN OTC DRUG LABEL	11