FDA.reportPublic FDA data

Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen

Product NDC
49967-409
11-digit product format
499670409
Labeler code
49967
Product ID
49967-409_9c24442b-9868-4269-b783-419171eda036
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-01
Substance
TITANIUM DIOXIDE
Active strength
150 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
eb43177e-389d-4572-8521-ee4d0a2dad3aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-409-01Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-01Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen50 mL in 1 TUBELOTION507
49967-409-02Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen5 mL in 1 TUBELOTION57
49967-409-02Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-03Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-03Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen50 mL in 1 BOTTLELOTION507
49967-409-04Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION17
49967-409-04Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen5 mL in 1 BOTTLELOTION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-409KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPERFLUID UV MINERAL DEFENSE BROAD SPECTRUM SPF 50 PLUS SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]7Current NDC, Legacy NDC, 8 package rows20231231_eb43177e-389d-4572-8521-ee4d0a2dad3a.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 298 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intensive Age Defying Hydrating Complex SPF 25HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONEJune Jacobs Labs, LLC18f59d9d-1328-d815-e063-6294a90a38012024-05-21WarningsExact identifier
application number: M020
Advanced Sun Resistance SPF 30HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONEJune Jacobs Labs, LLC18f879f0-3d5b-0067-e063-6394a90a9db32024-05-21WarningsExact identifier
application number: M020
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
application number: M020
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc18e7fc6b-b40a-f790-e063-6294a90ad0f42024-05-20WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
application number: M020
Vacation Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc150cbb23-fcb9-ed6f-e063-6394a90a597c2024-05-16WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66dfcec-ad40-3a0b-e053-2995a90aa0062024-05-14WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66c88a1-7684-1043-e053-2a95a90aa2aa2024-05-14WarningsExact identifier
application number: M020
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
application number: M020
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-30ZINC OXIDESABIYA, LLCbc403672-7576-49a6-9a29-4f6cb19af7a42024-05-09WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-50ZINC OXIDESABIYA, LLC4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c2024-05-09WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
application number: M020
UV Daily Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b4502024-05-09WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREENSwiss-American CDMO, LLC50f47495-93aa-4e11-a153-d4c847a36c992024-05-08WarningsExact identifier
application number: M020
UV Clear Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.ead07d51-9400-4f0a-8966-7052dfae67bc2024-05-08WarningsExact identifier
application number: M020
Essence Pout Protector SPF 20 Lip BalmHOMOSALATE, OCTISALATE, ZINC OXIDEcosnova GmbH17e483c5-6e47-9a50-e063-6394a90aa6042024-05-07Warnings, Adverse reactionsExact identifier
application number: M020
MIRABELLA Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONEGDM ENTERPRISES LLC3ac847d5-a75d-4b32-84e1-70e4282c0d722024-05-06WarningsExact identifier
application number: M020
MELAN SPF-30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEMELAN INC.75fcef12-bc33-44a7-acda-77d5d7bca2bc2024-05-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-409-01499670409011 TUBE in 1 CARTON (49967-409-01) / 50 mL in 1 TUBE1 tube2015-12-010000-00-00NoNoCurrent
49967-409-02499670409021 TUBE in 1 CARTON (49967-409-02) / 5 mL in 1 TUBE1 tube2015-12-010000-00-00NoNoCurrent
49967-409-03499670409031 BOTTLE in 1 CARTON (49967-409-03) / 50 mL in 1 BOTTLE1 bottle2015-12-010000-00-00NoNoCurrent
49967-409-04499670409041 BOTTLE in 1 CARTON (49967-409-04) / 5 mL in 1 BOTTLE1 bottle2015-12-010000-00-00NoNoCurrent