RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20

Product NDC: 59735-800
11-digit product format: 597350800
Labeler code: 59735
Product ID: 59735-800_4fafb975-37a0-0470-e063-6394a90aaf14
Type: HUMAN OTC DRUG
Nonproprietary name: RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20
Dosage form: CREAM
Route: TOPICAL
Labeler: PML NYC, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-01
Substance: AVOBENZONE; OCTINOXATE; OCTISALATE
Active strength: 2; 7.5; 5 g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59735-800		I	Inactivated by FDA	2026-11-13
excluded package	package	59735-800	59735-800-02	I	Inactivated by FDA	2026-11-13
excluded package	package	59735-800	59735-800-04	I	Inactivated by FDA	2026-11-13
excluded package	package	59735-800	59735-800-06	I	Inactivated by FDA	2026-11-13
excluded package	package	59735-800	59735-800-08	I	Inactivated by FDA	2026-11-13

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: RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	2 g/100g
OCTINOXATE	7.5 g/100g
OCTISALATE	5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	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
316d905f-232c-d8a2-e063-6394a90adbc9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59735-800-09	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	28 g in 1 TUBE	CREAM	28	5
59735-800-10	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	1 in 1 BOX	CREAM	1	5
59735-800-01	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	28 g in 1 TUBE	CREAM	28	3
59735-800-02	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	1 in 1 BOX	CREAM	1	3
59735-800-03	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	28 g in 1 TUBE	CREAM	28	3
59735-800-04	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	1 in 1 BOX	CREAM	1	3
59735-800-05	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	28 g in 1 TUBE	CREAM	28	3
59735-800-06	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	1 in 1 BOX	CREAM	1	3
59735-800-07	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	28 g in 1 TUBE	CREAM	28	3
59735-800-08	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	1 in 1 BOX	CREAM	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59735-800	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 CREAM [MANA PRODUCTS,INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250331_316d905f-232c-d8a2-e063-6394a90adbc9.zip
59735-800	RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 CREAM [MANA PRODUCTS,INC.]	3	Current NDC, Legacy NDC, 8 package rows	20240808_eab747ac-251a-a1e5-e053-2a95a90a5d84.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 314 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Deep	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	83725be5-4a0a-4717-a034-ff2999dd4099	2023-12-16	Warnings	Exact identifier application number: M020
Light Day Sunscreen SPF 37	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Circadia by Dr Pugliese, Inc.	16d76785-22a0-4a4b-a6f1-74056612e936	2023-12-15	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME NUDE SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	337a771e-c965-421a-a8e7-d853ffe51c2c	2023-12-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	b4cef09a-f0e4-4054-a200-667df7d150bf	2023-12-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	1f3b56d5-c33a-401f-8c8a-924345a4846e	2023-12-15	Warnings	Exact identifier application number: M020
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Isagenix International, LLC	6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce	2023-12-14	Warnings	Exact identifier application number: M020
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01	TITANIUM DIOXIDE	Orveon Global US LLC	29738578-6681-476e-8660-7219f58e8fa0	2023-12-13	Warnings	Exact identifier application number: M020
Sheer Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Allure Labs	0c6ac094-cb5b-0f09-e063-6394a90a9eed	2023-12-13	Warnings	Exact identifier application number: M020
REDEFINE Triple Defense	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Rodan & Fields	ed0209a6-a8ce-4394-bcf0-32d585a6b834	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	4e56f3f2-b856-4bbc-ab39-6fb5887a4846	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2ce83dc2-84b6-43fd-8b11-495d41cebc22	2023-12-13	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca	2023-12-13	Warnings	Exact identifier application number: M020
6000X Elemental Screen BS SPF 30 Sunscreen	ZINC OXIDE	Allure Labs	0c574a9a-edea-d333-e063-6394a90a41e3	2023-12-12	Warnings	Exact identifier application number: M020
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	Rodan & Fields	1a936053-2be0-4c52-a073-ba846b87f811	2023-12-12	Warnings	Exact identifier application number: M020
Beet the sun lightweight sunscreen broad spectrum spf 40 pa	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Krave Beauty, LLC	ff93d086-ec80-6bd5-e053-6294a90af019	2023-12-12	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Up The Anti	TITANIUM DIOXIDE, ZINC OXIDE	Biopelle, Inc.	37506766-370e-4ae4-8dbe-915a763e7c55	2023-12-12	Warnings	Exact identifier application number: M020
INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20	AVOBENZONE, OCTINOXATE, OCTISALATE	DermStore, LLC	19640e0c-c6b3-43b8-91e9-d8d9fff2e44e	2023-12-12	Warnings	Exact identifier application number: M020
Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen	ZINC OXIDE	Englewood Lab, Inc.	273d8e30-a6bc-4b26-919c-9332fd5197fa	2023-12-12	Warnings	Exact identifier application number: M020
Youth Activating BB SPF30 Shade 3	ZINC OXIDE, TITANIUM DIOXIDE	Englewood Lab, Inc.	c84207c4-a779-4c00-a486-86eaf8ece169	2023-12-12	Warnings	Exact identifier application number: M020
Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	c7526b69-d059-499a-9134-3a1f5d0471b3	2023-12-12	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
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59735-800-01	59735080001	28 g in 1 TUBE (59735-800-01)	28 g	2017-01-01	0000-00-00	No	No	Current
59735-800-02	59735080002	1 in 1 BOX						Historical
59735-800-03	59735080003	28 g in 1 TUBE	28 g					Historical
59735-800-04	59735080004	1 in 1 BOX						Historical
59735-800-05	59735080005	28 g in 1 TUBE	28 g					Historical
59735-800-06	59735080006	1 in 1 BOX						Historical
59735-800-07	59735080007	28 g in 1 TUBE	28 g					Historical
59735-800-08	59735080008	1 in 1 BOX						Historical
59735-800-09	59735080009	28 g in 1 TUBE	28 g					Historical
59735-800-10	59735080010	1 TUBE in 1 BOX (59735-800-10) / 28 g in 1 TUBE (59735-800-09)	1 tube	2017-01-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	PML NYC, LLC	2026-04-17	HUMAN OTC DRUG LABEL	5
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20	MANA PRODUCTS,INC. \| MANA PRODUCTS, INC	2024-08-02	HUMAN OTC DRUG LABEL	3