FDA.reportPublic FDA data

STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION

Product NDC
40046-0065
11-digit product format
400460065
Labeler code
40046
Product ID
40046-0065_efb8488a-8cde-cb54-e053-2995a90a6dca
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
MAKEUP ART COSMETICS
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
70 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct40046-0065DDiscontinued by firm2026-10-21
excluded packagepackage40046-006540046-0065-1DDiscontinued by firm2026-10-21

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0065-12022-08-04C16284748780-1e4f33bdf-b1e2-d8a0-e053-dadaa90a6e4eSTUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION
40046-0065-12022-07-29C16284748780-1e4f33bdf-b1e2-d8a0-e053-dadaa90a6e4eSTUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0065STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [MAKEUP ART COSMETICS]7Legacy NDC20241227_ab8f5c2b-9fd8-4cd6-b6de-deef7e4bd4d2.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 73 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SevenZINC OXIDEClean Beauty For All, Inc (dba Saie)310a07bb-d32a-401f-955e-4c2860148a302026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FiveZINC OXIDEClean Beauty For All, Inc (dba Saie)39ae4a97-7f96-4c95-a6de-0c779764fb022026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc3e-055c-e51d-e063-6294a90a00f52026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade NineZINC OXIDEClean Beauty For All, Inc (dba Saie)9c7a31df-5bdd-403b-b807-1d1a801e1bb62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade OneZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc51-ae53-acb8-e063-6394a90a14eb2026-01-20WarningsExact identifier
application number: M020
Wrinkle Repair Moisturizer SPF 30 EQBAVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%Walmarta067e968-e598-40ef-95f2-c338b5e413dd2026-01-20WarningsExact identifier
application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen KidsZINC OXIDE 14.69%S&C Hampton Sun LLC0bdb7d15-dc52-4e23-9417-fe73f17f61102026-01-20WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICKOCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATEDEWYTREE CO. ,LTD48406e68-eefd-d2c2-e063-6394a90a4ad92026-01-20WarningsExact identifier
application number: M020
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
application number: M020
CHUDAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEPremier Ocher LLC1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f2026-01-20WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
application number: M020
PROJECT REEF SPF-30 Mineral SunscreenZINC OXIDEProject Reef LLCa6077e6f-d987-4159-946f-3e23972476592026-01-19WarningsExact identifier
application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30ZINC OXIDESABAL SUN LLCf917b446-4e10-4231-826e-fdac32e111862026-01-19WarningsExact identifier
application number: M020
Plius Daily SPF Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEPLIUS, Inc31866de9-afa0-4c11-be65-b613735514932026-01-19WarningsExact identifier
application number: M020
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.6edc0941-bb21-4797-a875-81f7276947742026-01-19WarningsExact identifier
application number: M020
Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21)ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20%Grace and Fire USA Inc.48c1b93c-9c6f-95aa-e063-6294a90a0cfa2026-01-19WarningsExact identifier
application number: M020
ANUA INVISIBLE GLOW FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.446ac344-1078-4cd1-e063-6294a90a4bd42026-01-19WarningsExact identifier
application number: M020
ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.31af7b5e-2bd6-63ee-e063-6294a90a08062026-01-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40046-0065-1400460065011 TUBE in 1 CARTON (40046-0065-1) > 40 mL in 1 TUBE1 tube2011-09-010000-00-00NoNoCurrent