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	2026-10-23
excluded package	package	59735-800	59735-800-02	I	Inactivated by FDA	2026-10-23
excluded package	package	59735-800	59735-800-04	I	Inactivated by FDA	2026-10-23
excluded package	package	59735-800	59735-800-06	I	Inactivated by FDA	2026-10-23
excluded package	package	59735-800	59735-800-08	I	Inactivated by FDA	2026-10-23

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 203 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Face Reality Brilliant Defense Sunscreen SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Face Reality,LLC	618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce4	2025-07-29	Warnings	Exact identifier application number: M020
Face Reality Power Mineral Sunscreen SPF 50	ZINC OXIDE	Face Reality,LLC	8c502e11-6e97-46d6-8775-1bbafaeb18f8	2025-07-29	Warnings	Exact identifier application number: M020
SPF30 unseen sunscreen stick 01	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3afa3bdb-e924-55c1-e063-6394a90af352	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	003123d2-9675-fdd2-e063-6294a90a0130	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20e0badf-fe25-1d27-e063-6294a90a7cfe	2025-07-28	Warnings	Exact identifier application number: M020
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b016dcf-fb74-916f-e063-6294a90a683d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	3b01c6a4-2230-c83e-e063-6294a90aa66d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b022c84-00a5-ece9-e063-6294a90a09bd	2025-07-28	Warnings	Exact identifier application number: M020
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b02c3f2-a43a-0d29-e063-6394a90a76b5	2025-07-28	Warnings	Exact identifier application number: M020
KARA VITA Moisturizing Sunscreen with DNArescue	OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Kara Vita, Inc.	2130e9ac-5946-4b00-94d0-a78fd1ccfd13	2025-07-25	Warnings	Exact identifier application number: M020
78 x 36 SPF 30 Active	ZINC OXIDE	Dermazone LLC	96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55	2025-07-25	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	2ccf4e45-4cec-417d-9f4c-28f376025f1d	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 30 Active	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	5ec1510d-1465-4849-9e23-f16e11ff0e65	2025-07-25	Warnings	Exact identifier application number: M020
Skinuva Scar plus	ZINC OXIDE	MD Medical Designs, Inc.	5fcad8c3-a268-4966-b0a9-6cd2c7afd3b7	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 29 Active with DNArescue	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	99fb90ca-6527-459b-8af2-627ea9abe11b	2025-07-25	Warnings	Exact identifier application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd.	3aa93f52-ec01-01c2-e063-6294a90a9347	2025-07-24	Warnings	Exact identifier application number: M020
Mineral Suscreen SPF 30	ZINC OXIDE 19.0%	Vivant Pharmaceuticals, LLC	3aadb658-d12d-ae8d-e063-6394a90a6496	2025-07-24	Warnings	Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE 6.8%	Baxter of California, LLC	146030bc-2bf4-25ea-e063-6294a90a4613	2025-07-24	Warnings	Exact identifier application number: M020
Leg and Body Makeup Broad Spectrum SPF 25	OCTISALATE 3.2% OCTOCRYLENE 6%	Baxter of California, LLC	14adc826-6e9d-382a-e063-6294a90a5d79	2025-07-24	Warnings	Exact identifier application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20	AVOBENZENE, OCTINOXATE, OCTOCRYLENE	TIEGE HANLEY, Inc	22086cd8-2126-120e-e063-6394a90a561e	2025-07-24	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