FDA.reportPublic FDA data

REDNESS solutions DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15

Product NDC
49527-019
11-digit product format
495270019
Labeler code
49527
Product ID
49527-019_f07509ea-0023-2162-e053-2995a90ab76b
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
65 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49527-019IInactivated by FDA2026-11-13
excluded packagepackage49527-01949527-019-01IInactivated by FDA2026-11-13
excluded packagepackage49527-01949527-019-02IInactivated by FDA2026-11-13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-08-04REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15
2022-08-04REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15
2022-07-29REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15
2022-07-29REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-019-01REDNESS solutions DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 1540 mL in 1 BOTTLECREAM4011
49527-019-01REDNESS solutions DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 151 in 1 CARTONCREAM111
49527-019-02REDNESS solutions DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 1515 mL in 1 TUBECREAM1511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-019REDNESS SOLUTIONS DAILY PROTECTIVE BASE BROAD SPECTRUM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES LLC]11Legacy NDC, 3 package rows20250227_d4133b2c-54e1-43de-98b4-7908a52f0905.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 296 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATESICOS ET CIE3b49a970-653b-4256-b2d3-4e065db638492024-06-24WarningsExact identifier
application number: M020
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATEL'Oreal USA Products Inc.1b851e19-add0-437b-86e4-e88a10a1e7742024-06-24WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
application number: M020
Bitchstix Citrus Orange Broad Spectrum SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1b6bf419-554c-86a7-e063-6294a90a5a7e2024-06-21WarningsExact identifier
application number: M020
OS-01 Body SPF 30ZINC OXIDEAllure Labs1b582f4e-553f-a511-e063-6294a90af3c02024-06-20WarningsExact identifier
application number: M020
Seaweed Bath Co Playful Papaya Kids Sunscreen SPF 50ZINC OXIDEThe Seaweed Bath Co.65c9c131-2545-4d88-aa9a-85197b654d742024-06-19WarningsExact identifier
application number: M020
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
application number: M020
EB-5 Super Hydrating Anti-Aging SPF-50OCTOCRYLENE, ZINC OXIDE, OCTISALATELIFE O, INC.b9521112-d119-4d48-8504-4e46b434f76f2024-06-17WarningsExact identifier
application number: M020
Burts Bees SPF 30 Untinted Lip Balm Beaches and CreamBURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAMAutumn Harp1ac89261-eeae-567c-e063-6294a90ad45f2024-06-13WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
application number: M020
Mara Clear Skin Mineral Milk Acne TreatmentSALICYLIC ACIDMara Beauty LLC3823024e-81b4-4e29-af76-82231e09407c2024-06-13WarningsExact identifier
application number: M020
BOB KIDS SPF 30 Zinc onlyZINC OXIDESPF Ventures, LLC1aae0291-f16f-7840-e063-6394a90a34432024-06-12WarningsExact identifier
application number: M020
Glossier Invisible Shield SPF 50GLOSSIER INVISIBLE SHIELD SPF 50Autumn Harp1ab39eae-06e9-0e4c-e063-6394a90ad8aa2024-06-12WarningsExact identifier
application number: M020
Thinksport SPF 50ZINC OXIDEthinkOperations,LLC2e83e382-8eb0-40f2-bdca-2db5e184661e2024-06-10WarningsExact identifier
application number: M020
Thinkkids SPF 50ZINC OXIDEthinkOperations,LLC09f9d9bb-c08b-401c-bbf1-640f1c8ec6782024-06-07WarningsExact identifier
application number: M020
NAELI Day Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEALLI LLCf2cebdc7-c96e-46cf-9b5c-b4965ddd2aec2024-06-06WarningsExact identifier
application number: M020
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
application number: M020
Thinkbaby SPF 50ZINC OXIDEthinkOperations,LLCf2788a1a-daf6-4b7d-8333-585a380ebe572024-06-05WarningsExact identifier
application number: M020
RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTERZINC OXIDERms organics LLC1a11c884-d6ba-d77f-e063-6394a90a5bd22024-06-04WarningsExact identifier
application number: M020
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-019-01495270019011 BOTTLE in 1 CARTON (49527-019-01) > 40 mL in 1 BOTTLE1 bottle2011-12-010000-00-00NoNoCurrent
49527-019-024952700190215 mL in 1 TUBE15 mlHistorical