FDA.reportPublic FDA data

Dr.Jart Premium Beauty Balm Deep Tan-Deep

Product NDC
49404-151
11-digit product format
494040151
Labeler code
49404
Product ID
49404-151_47ed29d2-e63e-7242-e063-6294a90a5c9b
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Have & Be Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-25
Substance
TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength
4.8; 5; 6.8; 4.5 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Premium Beauty Balm Deep Tan-Deep
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE4.8 g/100mL
ZINC OXIDE5 g/100mL
OCTINOXATE6.8 g/100mL
OCTISALATE4.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal 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
3c346960-b76b-4241-a188-8ee694853078Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49404-151-022024-01-30C16284748780-11030e365-6472-111a-e063-dadaa90a10e249404-151 Dr.Jart+ Premium Beauty Balm Deep Tan-Deep
49404-151-022024-01-30C16284748780-11030e365-6472-111a-e063-dadaa90a10e249404-151 Dr.Jart+ Premium Beauty Balm Deep Tan-Deep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49404-151-02Dr.Jart Premium Beauty Balm Deep Tan-Deep1 in 1 CARTONCREAM13
49404-151-02Dr.Jart Premium Beauty Balm Deep Tan-Deep40 mL in 1 BOTTLE, PUMPCREAM403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49404-151DR.JART PREMIUM BEAUTY BALM DEEP TAN-DEEP (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20240621_3c346960-b76b-4241-a188-8ee694853078.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 88 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION7d9c0f81-005f-4223-940e-a64143db52752026-01-06WarningsExact identifier
application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)31e976a2-0623-0dca-e063-6394a90a08da2026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)315a5ca4-4536-d585-e063-6294a90a1c502026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION51f759b7-8c49-41d4-aaa3-f901d599cac52026-01-06WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION463dc557-9743-4a38-969e-2c78fc10ee2a2026-01-06WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION23bb4225-bfb5-47e2-80fe-733761ba40692026-01-06WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONe881e637-e0f0-4c90-8343-2be6e74020b82026-01-06WarningsExact identifier
application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONd308d578-c881-4c10-8c79-9e3cd58b694c2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC051b7413-8f1b-7135-e063-6294a90a93642026-01-06WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Inc47bc6776-1130-0162-e063-6294a90a2adc2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsExact identifier
application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Love LetterAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD47d22c6d-49fd-f97c-e063-6294a90a6ba12026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ab90db-51bd-ffb3-e063-6294a90a852b2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ac28e7-41f1-bd4e-e063-6294a90a0e7b2026-01-06WarningsExact identifier
application number: M020
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49404-151-02494040151021 BOTTLE, PUMP in 1 CARTON (49404-151-02) / 40 mL in 1 BOTTLE, PUMP2022-04-250000-00-00NoNoCurrent