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 158 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c9d86-45d7-efcc-e063-6394a90acefb	2025-11-23	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	615c5349-7fff-4145-9d65-1687247163be	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	3cee59ad-f5e1-487d-b9cc-597664c62dac	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0e905f47-a1d8-4c5a-8247-d7328d2cb4af	2025-11-21	Warnings	Exact identifier application number: M020
SPF 50 Sport Sunscreen GoodSense	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Geiss, Destin, & Dunn, Inc	a22baebd-1f4d-6eae-e053-2a95a90afe51	2025-11-21	Warnings	Exact identifier application number: M020
Everyday Sun Defense	ZINC OXIDE	Hommerejuvenate, Inc.	05aa1a1a-9e4f-2781-e063-6394a90aef6b	2025-11-21	Warnings	Exact identifier application number: M020
innisfree Daily UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, AND OCTISALATE LOTION	Innisfree Corporation	0e9b6697-28a3-f69f-e063-6394a90a9d11	2025-11-20	Warnings	Exact identifier application number: M020
SULWHASOO PERFECTING CUSHION NO. 15	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Amorepacific Corporation	8d420e4b-c778-3ed4-e053-2995a90a59a9	2025-11-20	Warnings	Exact identifier application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Norwex Usa, Inc.	f527a8c5-b05e-5f3c-e053-2995a90aa1a3	2025-11-20	Warnings	Exact identifier application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 Hazelnut	ZINC OXIDE	Norwex Usa, Inc.	440bd831-ee0b-b527-e063-6294a90a9333	2025-11-20	Warnings	Exact identifier application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Elemis Ltd.	23f9222f-60ba-72fb-e063-6394a90a9965	2025-11-20	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie Repellant	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca866e-adc3-5a4f-e063-6394a90a1d1d	2025-11-20	Warnings	Exact identifier application number: M020
Sandra Plasencia Green Tea Daily SPF 50 Moisturizer	TITANIUM DIOXIDE	Sandra Plasencia Skincare	43ef1f93-0e89-0a35-e063-6394a90afb51	2025-11-19	Warnings	Exact identifier application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50	ZINC OXIDE	Sunkissed By Heaven, LLC	09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d	2025-11-19	Warnings	Exact identifier application number: M020
KOVR Military grade sunscreen for women	ZINC OXIDE	ACTIVE LIFE INC	4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae	2025-11-19	Warnings	Exact identifier application number: M020
Dynamic Resurfacing SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	fc64720c-060c-4f33-8c76-96456fac270d	2025-11-19	Warnings	Exact identifier application number: M020
Daily Defence Shield SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	b2b6de93-47c8-4b6e-9fb9-8bdc8909271a	2025-11-19	Warnings	Exact identifier application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32	ZINC OXIDE	DUKE CANNON SUPPLY CO.	0c47278b-2ec2-81ab-e063-6294a90ac937	2025-11-19	Warnings	Exact identifier application number: M020
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	03b0f2ee-526b-4513-b70a-2918ad322b5e	2025-11-19	Warnings	Exact identifier application number: M020
Invisible Sunscreen SPF 40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	PARTICLE AESTHETIC SCIENCE LTD	1b33b4fb-1deb-69f7-e063-6294a90a9cc0	2025-11-19	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