FDA.reportPublic FDA data

SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50

Product NDC
49967-992
11-digit product format
499670992
Labeler code
49967
Product ID
49967-992_ea4a7d45-6c3e-497f-b5c1-0a498b1daf48
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Octocrylene and Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-01
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
80; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE80 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE50 mg/mL
ZINC OXIDE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal 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
817c882d-72f3-4ee7-8da2-a4a32f9d167fAvailable 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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-992-01SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 5030 mL in 1 JARLOTION301
49967-992-01SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION11
49967-992-02SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 504 mL in 1 TUBELOTION41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-992SKINCEUTICALS CLEAR DAILY SOOTHING UV DEFENSE DAILY SUNSCREEN BROAD SPECTRUM SPF 50 (HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]1Current NDC, 3 package rows20240716_817c882d-72f3-4ee7-8da2-a4a32f9d167f.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 322 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
application number: M020
BEAST SPIT and POLISH FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC27e5244b-4b69-4dec-9dd5-ba8b71b171b22023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLCbd60cf89-e0e9-48ad-b174-1ecf72557d9c2023-11-11WarningsExact identifier
application number: M020
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLC6d6b5b2a-210a-4606-9cdb-f6eec10f37e82023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Baby Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCac66ad82-a01f-4e44-92a7-b5ab5bd309222023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Daily Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLC1745dc35-648e-4315-a285-c99ebeef4f6a2023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Face Factor Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCedc2c1e7-e1a8-4b49-96df-8a94eb6a242a2023-11-11WarningsExact identifier
application number: M020
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF 50 SPORTOCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.f01516bf-8aed-4402-a3f9-ef11c54d46b32023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF-30OCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.4df55434-fb9a-442d-82cf-16a4957f0a2a2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-30ZINC OXIDEProject Reef LLCb7de9ec2-6db1-4c89-b734-15c4bd5c32512023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO Cooling Mist SPF-60 SportHOMOSALATE, OCTISALATE, ZINC OXIDEThe Seaweed Bath Co.98ccbb70-6e1a-4e92-a095-cbc4be12fcbf2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
application number: M020
YOUTH CORRIDOR Soothe and Defend SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEYouth Corridor5c0873ff-8e76-48de-919d-f69794c4bd372023-11-11WarningsExact identifier
application number: M020
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDEZITSTICKA, Inc32164318-7a7e-40b2-99da-8246c99fdbd32023-11-11WarningsExact identifier
application number: M020
SUNNY Q Broad Spectrum SPF-30ZINC OXIDESunny Q Sunscreen LLC593870fa-425c-401c-ac26-f63f4ce0298f2023-11-11WarningsExact identifier
application number: M020
BRICKELL Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC44806b83-9220-4d34-806d-20cf0a47186e2023-11-11WarningsExact identifier
application number: M020
BRICKELL Element Defense Moisturizer SPF-45OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC94be278a-3773-469b-8e40-3242d1072a3d2023-11-11WarningsExact identifier
application number: M020
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEThirty7 LLC6ff00b6e-1cc7-4cc4-842b-4e379f75e4542023-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-992-01499670992011 JAR in 1 CARTON (49967-992-01) / 30 mL in 1 JAR1 jar2024-05-01NoNoCurrent
49967-992-02499670992024 mL in 1 TUBE (49967-992-02) 4 ml2024-05-01NoNoCurrent