FDA.reportPublic FDA data

DR.JART EVERY SUN DAY MINERAL SUN SCREEN

Product NDC
49404-153
11-digit product format
494040153
Labeler code
49404
Product ID
49404-153_47ed472b-224a-5b9a-e063-6394a90a7030
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Have & Be Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-22
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
115; 41 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
DR.JART EVERY SUN DAY MINERAL SUN SCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE115 mg/mL
TITANIUM DIOXIDE41 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f06c31b4-da5f-6495-e053-2995a90ae67cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
49404-153-01[NEW] Dr.Jart Every Sun Day Mineral Sun Screen
49404-153-01[NEW] Dr.Jart Every Sun Day Mineral Sun Screen
49404-153-02[NEW] Dr.Jart Every Sun Day Mineral Sun Screen
49404-153-02[NEW] Dr.Jart Every Sun Day Mineral Sun Screen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49404-153-01DR.JART EVERY SUN DAY MINERAL SUN SCREEN1 in 1 CARTONCREAM15
49404-153-01DR.JART EVERY SUN DAY MINERAL SUN SCREEN50 mL in 1 TUBECREAM505
49404-153-02DR.JART EVERY SUN DAY MINERAL SUN SCREEN5 mL in 1 TUBECREAM55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49404-153DR.JART EVERY SUN DAY MINERAL SUN SCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HAVE & BE CO., LTD.]4Current NDC, Legacy NDC, 3 package rows20241227_f06c31b4-da5f-6495-e053-2995a90ae67c.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 248 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b2b-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44cb-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b2b996-e02c-e40a-e063-6394a90aa0d92024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e1-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42d0-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edc9-1ebd-e063-6294a90aee132024-12-25WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION29fe531e-2ade-170f-e063-6394a90a13962024-12-24WarningsExact identifier
application number: M020
SOLAR MILK SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION29fe4dad-d1fb-e750-e063-6294a90ab3072024-12-24WarningsExact identifier
application number: M020
CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Incd30cc344-846d-416e-ac57-4a29d4ed82632024-12-24WarningsExact identifier
application number: M020
Almay Age Smart Shade CC Luminous Primer SPF 15ZINC OXIDE, TITANIUM DIOXIDE MAKE-UPAlmay, Inc.281557c0-e668-4436-86a7-3f583091e4e42024-12-24WarningsExact identifier
application number: M020
EIGHT HOUR LIP PROTECTANT SPF 15PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONEREVLON2a0ac6aa-0315-d79e-e063-6294a90a9c532024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcc-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Buff BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38b-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 HazelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38c-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Cool BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b48b8-5953-9ab7-e063-6394a90a6b242024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Creamy NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcd-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich MahoganyFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-883b-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light TanFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b557a-ff60-f33f-e063-6394a90ac66f2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-8839-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b668d-036e-893e-e063-6294a90a82af2024-12-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49404-153-01494040153011 TUBE in 1 CARTON (49404-153-01) / 50 mL in 1 TUBE1 tube2022-12-220000-00-00NoNoCurrent
49404-153-02494040153025 mL in 1 TUBE (49404-153-02) 5 ml2022-12-220000-00-00NoNoCurrent