FDA.reportPublic FDA data

KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN

Product NDC
82046-762
11-digit product format
820460762
Labeler code
82046
Product ID
82046-762_52f70849-e93b-2db5-e063-6294a90ab59e
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
L�Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-27
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
26.6; 153.5 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
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE26.6 mg/mL
ZINC OXIDE153.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
294e6049-12b5-4b45-ae00-8ee1d9d2a1a4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-762-01KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN1 in 1 CARTONCREAM11
82046-762-01KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN40 mL in 1 TUBECREAM401

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 227 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow SerumZINC OXIDE 20%EMMA LEWISHAM US, INC.2b097709-913f-d906-e063-6394a90a04462025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2c703df8-23af-d630-e063-6294a90a1a242025-02-05WarningsExact identifier
application number: M020
doTERRA SunZINC OXIDEdoTERRA International, LLCdd308fef-e312-4ced-e053-2995a90a76fd2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 15gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDb686ef63-7eee-4a4d-a559-417d8b09cc4f2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 22gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDd3c422f6-a83d-48fc-94fc-2749666426c82025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2d65b2d0-7013-d0ad-e063-6394a90ad4c22025-02-05WarningsExact identifier
application number: M020
Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2d6a6fed-a26e-e3a6-e063-6394a90ae2c72025-02-05WarningsExact identifier
application number: M020
Brush On Block Sheer Genius SPF 50 Mineral MoistureZINC OXIDESPF Ventures, LLC2d4b8c92-b932-89a7-e063-6394a90a621d2025-02-04WarningsExact identifier
application number: M020
Seven Thirty Daily Habit Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY30ca8f9d-b6a5-4af0-9d7b-487212e40e632025-02-03WarningsExact identifier
application number: M020
Atlanta Acne Specialist Everyday Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY3057f8ad-5850-49a0-b44d-3a1da84126e32025-02-03WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD.2d3faa43-0d78-58de-e063-6294a90a0b172025-02-03WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d40099a-2cfa-1d99-e063-6394a90a36a62025-02-03WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-RefillZINC OXIDESPF Ventures, LLC2d47eb76-e644-4e04-e063-6294a90a93cc2025-02-03WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONESkin Ai, LLC2d8b7d07-2249-898b-e063-6394a90af6ad2025-02-01WarningsExact identifier
application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c79f1a-cecd-2409-e053-2995a90ad06f2025-01-31WarningsExact identifier
application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields67b55df8-9623-4352-b136-b0bc8d1efe022025-01-31WarningsExact identifier
application number: M020
Oil-Free Daily Hydration SPF 15OCTINOXATE, AVOBENZONEBoscia LLCec322ae5-ab03-4c7b-9c6d-0bda3327c72a2025-01-31WarningsExact identifier
application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
application number: M020
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82046-762-01820460762011 TUBE in 1 CARTON (82046-762-01) / 40 mL in 1 TUBE1 tube2026-05-27NoNoCurrent
82046-762-02820460762021 TUBE in 1 CARTON (82046-762-02) / 5 mL in 1 TUBE1 tube2026-05-27NoNoCurrent
82046-762-03820460762031 TUBE in 1 CARTON (82046-762-03) / 15 mL in 1 TUBE1 tube2026-05-27NoNoCurrent