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 326 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3WOCTISALATE, TITANIUM DIOXIDEGuerlain15fe0429-720c-4975-953d-285aa7ee12ce2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4WOCTISALATE, TITANIUM DIOXIDEGuerlain1a733548-75a4-41ec-8d8d-3e6e9aad52e02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8NOCTISALATE, TITANIUM DIOXIDEGuerlainf43c867a-161f-47b7-b3d8-7f7e6c6728042023-11-08WarningsExact identifier
application number: M020
Aruba Sun SPF 70 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd96b4233-6d52-7621-e053-2a95a90a1b602023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0COCTISALATE, TITANIUM DIOXIDEGuerlain0d75be99-7607-4964-bb6e-3c731644ab4e2023-11-08WarningsExact identifier
application number: M020
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltddee4bdb8-5c6f-42f6-b15c-d109cd2d31402023-11-08WarningsExact identifier
application number: M020
Mineral Radiance Energizing Day BS SPF 15AVOBENZONE, HOMOSALATE, AND OCTISALATEAHAVA Dead Sea Laboratories Ltd4cb8b21c-7727-441a-9d61-c90d79ac45dc2023-11-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Passion FruitAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLCf34beb68-e5dc-45c4-a6d1-e9a0310162282023-11-08WarningsExact identifier
application number: M020
Private Label SPF45 Water Resistant Paraben Free SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCf997f4fc-7da5-433c-9a53-2030b489b4f62023-11-07WarningsExact identifier
application number: M020
Private Label Moisturizing Oil Free Paraben Free SPF43SUNSCREENSwiss-American CDMO, LLC003e4221-f9d9-47c4-b10b-9876046b931a2023-11-07WarningsExact identifier
application number: M020
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltd5a9ec221-a9ec-4473-8fb0-83f10ae775e22023-11-07WarningsExact identifier
application number: M020
Private Label Super Light Oil-Free SPF452.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC6a08448a-46bc-4330-ae2d-f716bb4edfa72023-11-07WarningsExact identifier
application number: M020
GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30OCTINOXATE, OCTISALATE, ZINC OXIDETT Fitness, Inc617ef3af-4203-4664-b714-1b5fab2e0ee62023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Clear Moisture Mineral SPF-30ZINC OXIDEThe Seaweed Bath Co.c241261c-d887-4ac2-89ce-93dcc0fce2672023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Let It Sun Sunscreen SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC88628c11-dbc7-4404-9701-7944a685a13d2023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50ZINC OXIDEThe Seaweed Bath Co.fdcfc7eb-da33-4461-a4f9-fe97ea6b873f2023-11-06WarningsExact identifier
application number: M020
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42TITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC82d210bc-b7ca-4d74-be58-85f175a750582023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-50 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INC183e523a-93ee-47ec-8bd4-5557af449ea52023-11-06WarningsExact identifier
application number: M020
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC4e05e9d6-5127-44ca-a331-3004b2ddb5342023-11-06WarningsExact 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