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 FDA2026-10-23
excluded packagepackage59735-80059735-800-02IInactivated by FDA2026-10-23
excluded packagepackage59735-80059735-800-04IInactivated by FDA2026-10-23
excluded packagepackage59735-80059735-800-06IInactivated by FDA2026-10-23
excluded packagepackage59735-80059735-800-08IInactivated by FDA2026-10-23

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
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 215 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Good kids mineral sunscreen butter stick SPF 50ZINC OXIDEElemental Herbs, Inc.feb94fd7-6727-6fb1-e053-6394a90a2af12025-05-05WarningsExact identifier
application number: M020
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
application number: M020
EVERY DAY MINERAL SUN SCREEN SPF 45ZINC OXIDEStream2Sea, LLC7ec4954f-7d60-405b-8bff-cb602fc44a4e2025-05-04WarningsExact identifier
application number: M020
ABIB QUICK AND AIRY SUNSTICK DUO SETHOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.34292261-4d05-e07d-e063-6294a90a47412025-05-02WarningsExact identifier
application number: M020
LION POSE UNGHOSTED TINTED MINERAL SPF 42 UVA UVB SUNSCREENZINC OXIDELion Pose Inc.341b90b4-82ae-e8c6-e063-6394a90aeefd2025-05-01WarningsExact identifier
application number: M020
LAPCOS DAILY SUNSCREEN SPF 50SUNSCREENLAP USA, INC.337c3528-5739-6b4a-e063-6294a90a3cb42025-05-01WarningsExact identifier
application number: M020
Hiya Kids SPF 40 Mineral SunscrenZINC OXIDEHiya Health Products LLC33119ec6-2cd8-8978-e063-6394a90afd972025-05-01WarningsExact identifier
application number: M020
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLCce93b371-26ab-4493-98e0-98234c3a9ba62025-05-01WarningsExact identifier
application number: M020
Winter Rescue KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.24356548-348d-2cd2-e063-6294a90ab3522025-04-29WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 CLEARLIP 30 CLEARThe Center Brands, LLC33d5d1d4-c516-238c-e063-6294a90ac11c2025-04-28WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBEL STAR SA33db89ac-2653-78f5-e063-6394a90af03d2025-04-28WarningsExact identifier
application number: M020
LifeguardSUNSCREENSPHERE 8 INC32be4eb3-f106-182d-e063-6394a90aa4842025-04-28WarningsExact identifier
application number: M020
Practical Alchemy Purify and Protect DuoMICELLAR WATER WIPES AND ZINC OXIDEOver Here, LLC28514e58-59a6-094a-e063-6394a90a1c7d2025-04-28WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380a271-1538-2e3a-e063-6294a90a90a22025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380f1ac-0320-35f2-e063-6394a90a97eb2025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDE 15%Yunqi Cosmetics (Shenzhen) Co., Ltd33813fe1-8496-d541-e063-6294a90a62542025-04-24WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTISALATE, OCTOCRYLENE, ZINC OXIDEImpact Melanoma Incba78aa73-a25b-4a8e-99b2-9262bb9a7d272025-04-24WarningsExact identifier
application number: M020
Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company42819c8d-cc0a-4bee-95db-39a69ce7f6602025-04-24WarningsExact 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