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 204 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Counter Beauty Dew Skin Tinted Moisturizer No. 4ZINC OXIDEG2G Ventures, PBC3a35f23b-3732-db3c-e063-6294a90ae00c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5ZINC OXIDEG2G Ventures, PBC3a35fd79-f4d3-5ccf-e063-6294a90a97982025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6ZINC OXIDEG2G Ventures, PBC3a360053-5863-95fe-e063-6394a90a45c52025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8ZINC OXIDEG2G Ventures, PBC3a362e05-3a1e-8059-e063-6294a90ad5252025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7ZINC OXIDEG2G Ventures, PBC3a3621c2-709a-82fd-e063-6294a90a7a7e2025-07-18WarningsExact identifier
application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc3a39ac31-85c9-5e04-e063-6394a90aa5372025-07-18WarningsExact identifier
application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3afeda-f235-eac2-e063-6294a90a5a932025-07-18WarningsExact identifier
application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3b5f56-aa36-01c7-e063-6294a90a6d622025-07-18WarningsExact identifier
application number: M020
Counter Beauty Daily Sheer Defense SPF 25ZINC OXIDEG2G Ventures, PBC3a22d88b-cdb5-5656-e063-6294a90a5b772025-07-17WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 1ZINC OXIDEG2G Ventures, PBC3a2676ed-087d-f957-e063-6294a90ad4572025-07-17WarningsExact identifier
application number: M020
Sjolie Tanning SPF 30 SunscreenZINC OXIDESJOLIE, INC.3a283a09-2edb-f92c-e063-6294a90a82bd2025-07-17WarningsExact identifier
application number: M020
Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC32889c1e-d539-4b36-b012-9789c4a8d6422025-07-16WarningsExact identifier
application number: M020
GZE Tinted SunscreenZINC OXIDE 3%Guangzhou Yilong Cosmetics Co.,Ltd.182612d8-76a4-44a1-e063-6394a90a8d5f2025-07-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC089b798b-829f-aa86-e063-6294a90a86312025-07-15WarningsExact identifier
application number: M020
MO HANDSOME Protection Sport Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE8 PINE DESIGN LLC982ada30-5f87-42c6-b9ea-fedd842aa09d2025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUNSTICKAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEDONGDONGGURIMOO CO.,LTD.39eea41c-8703-cf1f-e063-6394a90a5b1f2025-07-14WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e7be0-97a6-ada5-e063-6294a90ae25a2025-07-14WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc48980ef3-ebda-450e-9f15-effad27dec9a2025-07-11WarningsExact 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