FDA.reportPublic FDA data

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59735-800IInactivated by FDA2026-10-15
excluded packagepackage59735-80059735-800-02IInactivated by FDA2026-10-15
excluded packagepackage59735-80059735-800-04IInactivated by FDA2026-10-15
excluded packagepackage59735-80059735-800-06IInactivated by FDA2026-10-15
excluded packagepackage59735-80059735-800-08IInactivated by FDA2026-10-15

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
IngredientStrength
AVOBENZONE2 g/100g
OCTINOXATE7.5 g/100g
OCTISALATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
316d905f-232c-d8a2-e063-6394a90adbc9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-800-09RETEXTURIZING PRIMER BROAD SPECTRUM SPF 2028 g in 1 TUBECREAM285
59735-800-10RETEXTURIZING PRIMER BROAD SPECTRUM SPF 201 in 1 BOXCREAM15
59735-800-01RETEXTURIZING PRIMER BROAD SPECTRUM SPF 2028 g in 1 TUBECREAM283
59735-800-02RETEXTURIZING PRIMER BROAD SPECTRUM SPF 201 in 1 BOXCREAM13
59735-800-03RETEXTURIZING PRIMER BROAD SPECTRUM SPF 2028 g in 1 TUBECREAM283
59735-800-04RETEXTURIZING PRIMER BROAD SPECTRUM SPF 201 in 1 BOXCREAM13
59735-800-05RETEXTURIZING PRIMER BROAD SPECTRUM SPF 2028 g in 1 TUBECREAM283
59735-800-06RETEXTURIZING PRIMER BROAD SPECTRUM SPF 201 in 1 BOXCREAM13
59735-800-07RETEXTURIZING PRIMER BROAD SPECTRUM SPF 2028 g in 1 TUBECREAM283
59735-800-08RETEXTURIZING PRIMER BROAD SPECTRUM SPF 201 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-800RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 CREAM [MANA PRODUCTS,INC.]4Current NDC, Legacy NDC, 2 package rows20250331_316d905f-232c-d8a2-e063-6394a90adbc9.zip
59735-800RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 CREAM [MANA PRODUCTS,INC.]3Current NDC, Legacy NDC, 8 package rows20240808_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 59 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab66c16-5f4c-6987-e063-6294a90add862026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
Seonglow Daily Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeonGlow Inc.01f3479f-3a0d-420b-bbf8-62a0a225bc9b2026-02-26WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab5d5ca-26bf-1c5f-e063-6394a90a00ca2026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
SPF50 Moisturizer with Aloe, Green Tea and Shea ButterZINC OXIDEAudrey Morris Cosmetics International, LLC92960e14-9845-49aa-b3ce-c8023aa109b62026-02-26WarningsExact identifier
application number: M020
Naturalessa SPF50 MoisturizerZINC OXIDEAudrey Morris Cosmetics International, LLC816ddfa1-cb55-4591-a90b-71631cb176262026-02-26WarningsExact identifier
application number: M020
UV DEFENSE FACE MINERAL SPF 50ZINC OXIDEBETTER INVENTION LTD4b9a9efe-9aba-0ed0-e063-6394a90a2c6b2026-02-26WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE SUNSCREEN SPF50AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9043-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9041-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
Rationale The Discovery Travel KitZINC OXIDERATIONALE GROUP PTY LTD0c919aea-4bd4-427e-97e7-9c153b42f4912026-02-25WarningsExact identifier
application number: M020
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLCebfb149c-0371-4492-b03a-5fdcb78217532026-02-25WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE Protective DayAVOBENZONE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporationdea8e4c1-6a9c-44c6-abc8-6cdd50f35f492026-02-25WarningsExact identifier
application number: M020
Aura DefenseZINC OXIDEGrace and Glow MD LLC4ba75eff-74ef-278b-e063-6394a90a8ef02026-02-25WarningsExact identifier
application number: M020
AM Shield plusZINC OXIDEGrace and Glow MD LLC4ba7c282-c68e-8719-e063-6394a90a38142026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 25SUNSCREENPerson and Covey6b9258e4-c7c6-765e-e053-2991aa0a9f4e2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac1c33-36fe-8d29-e063-6394a90a32a52026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac5550-c45f-a738-e063-6394a90ae5c82026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baca374-7aaa-8d1d-e063-6394a90a5a552026-02-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59735-800-015973508000128 g in 1 TUBE (59735-800-01) 28 g2017-01-010000-00-00NoNoCurrent
59735-800-02597350800021 in 1 BOXHistorical
59735-800-035973508000328 g in 1 TUBE28 gHistorical
59735-800-04597350800041 in 1 BOXHistorical
59735-800-055973508000528 g in 1 TUBE28 gHistorical
59735-800-06597350800061 in 1 BOXHistorical
59735-800-075973508000728 g in 1 TUBE28 gHistorical
59735-800-08597350800081 in 1 BOXHistorical
59735-800-095973508000928 g in 1 TUBE28 gHistorical
59735-800-10597350800101 TUBE in 1 BOX (59735-800-10) / 28 g in 1 TUBE (59735-800-09) 1 tube2017-01-01NoNoCurrent