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 22 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unseen Sunscreen SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Supergoop LLC	21b3491f-7b02-9bc5-e063-6294a90a0dc3	2026-06-04	Warnings	Exact identifier application number: M020
Mineral Glowscreen Soft-Radiance Drops Golden Hour	ZINC OXIDE	Supergoop LLC	1f1be2a7-af96-d73d-e063-6394a90acc1a	2026-06-04	Warnings	Exact identifier application number: M020
Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	975402e6-8c74-b18e-e053-2995a90a467e	2026-06-04	Warnings	Exact identifier application number: M020
Derma E Sun Drops SPF 30	ZINC OXIDE	derma e	76c29f24-e0d9-4235-b278-96e609bc58db	2026-06-04	Warnings	Exact identifier application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GB	ZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDE	HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED	5354af18-50c4-5fba-e063-6394a90ace39	2026-06-03	Warnings	Exact identifier application number: M020
ATOMY BB SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b0cd27ee-4917-4800-bcdf-c6e14b28c1d1	2026-06-02	Warnings	Exact identifier application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	ad0b9091-a990-45bf-93f4-d886be1bbffe	2026-06-02	Warnings	Exact identifier application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	994d5680-284e-4faf-a29b-4d28f8d46e8f	2026-06-02	Warnings	Exact identifier application number: M020
BLDG Active Skin Repair Sun Stick Performance Sunscreen	ZINC OXIDE	Innovacyn, Inc.	a751fc1d-5ee4-4ecc-8ade-2568d91890c4	2026-06-02	Warnings	Exact identifier application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE	HOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATE	HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED	5347c9a1-2239-b617-e063-6294a90ac601	2026-06-02	Warnings	Exact identifier application number: M020
Sungboon Editor Hydro Booster Moisture Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Olive International Co., Ltd.	4ea2292a-571c-475c-a64c-cbdd1f51f242	2026-06-02	Warnings	Exact identifier application number: M020
Sungboon Editor Daily Invisible Blurring Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Olive International Inc.	42325963-0917-43c4-8fe0-130336c7fa81	2026-06-02	Warnings	Exact identifier application number: M020
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40	ZINC OXIDE, TITANIUM DIOXIDE	Private Label Skin Care	a8d60212-18a7-42af-8bb3-bfcff7690a49	2026-06-02	Warnings	Exact identifier application number: M020
The Mineral Melt SPF30	ZINC OXIDE, TITANIUM DIOXIDE	Dune Suncare Inc.	2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3	2026-06-02	Warnings	Exact identifier application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	a1acb789-5bf4-4447-b3c5-4a7d4d3013a7	2026-06-01	Warnings	Exact identifier application number: M020
4ocean REEF SAFE SUNSCREEN SPF 40	ZINC OXIDE	Stream2Sea, LLC	52d3d97c-a846-4721-acbe-52a525cb2011	2026-06-01	Warnings	Exact identifier application number: M020
APRILSKIN MUGWORT CALMING SUNSCREEN	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	APR US INC	50a7b64a-8b26-97ac-e063-6294a90ad77a	2026-06-01	Warnings	Exact identifier application number: M020
Ultra Violette Future Screen Broad Spectrum SPF 50	ZINC OXIDE	Grace and Fire USA Inc.	252fdc91-bbe2-58ec-e063-6294a90a5067	2026-06-01	Warnings	Exact identifier application number: M020
Ultra Violette Vibrant Screen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Grace and Fire USA Inc.	2633a289-b3b2-b614-e063-6294a90ad214	2026-06-01	Warnings	Exact identifier application number: M020
Ultra Violette Sequin Supreme SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Grace and Fire USA Inc.	41027faa-7d61-4970-e063-6294a90a7df4	2026-06-01	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