FDA.reportPublic FDA data

Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen

Product NDC
49967-053
11-digit product format
499670053
Labeler code
49967
Product ID
49967-053_2d2e8d69-d4ee-4152-8076-a6cfe5ac48f1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 70; 50; 70 mg/mL; mg/mL; mg/mL; 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 Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE70 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48980ef3-ebda-450e-9f15-effad27dec9aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-053-01Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen50 mL in 1 BOTTLELOTION503
49967-053-01Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION13
49967-053-02Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen15 mL in 1 TUBELOTION153
49967-053-02Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION13
49967-053-03Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen2 mL in 1 PACKETLOTION23
49967-053-04Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen1 in 1 CARTONLOTION13
49967-053-04Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen100 mL in 1 BOTTLELOTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-053KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN UV SERUM BROAD SPECTRUM SPF 50 PLUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]2Current NDC, 7 package rows20231231_48980ef3-ebda-450e-9f15-effad27dec9a.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 68 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCdd036e0c-0c27-42b3-9d2c-33839a8631f92026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea23616f-1d59-4e32-88bb-d035af7277282026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic TwistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC21b6239b-26d0-4b6b-8aee-fe1f20d8aaea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC483b6873-fe58-4a38-bf82-df116617c5f02026-01-27WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50 MINERALS&C Hampton Sun4960930e-a1bf-d850-e063-6294a90a40842026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
application number: M020
Golden Glow SHIMMER MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD4963e513-d1fc-4b0e-e063-6394a90a7ddf2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD496ba4c4-6577-88ff-e063-6294a90a09952026-01-27WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.b442530f-cae3-418b-9675-c188796538262026-01-27WarningsExact identifier
application number: M020
EltaMD UV Clear Blemish-Prone and Oil BalancingOCTINOXATE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6337b9e3-2524-4292-8fc8-1f6aad6cfe052026-01-27WarningsExact identifier
application number: M020
SPF Ginger Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESPF GINGER LLCf303ad78-5fa3-40d1-9b1c-53ae1ca73aed2026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC8506049f-cb43-4d1d-885b-c6d3a99bbba32026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC144178e7-2df9-49c3-9667-43986cee89c42026-01-26WarningsExact identifier
application number: M020
ALOE KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC62016e94-b5d2-4ba2-ab9c-b0b2c1ead6502026-01-26WarningsExact identifier
application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%SPF 45 FACES&C Hampton Sun LLCe49808c9-5025-4965-8679-7fe824cf69072026-01-26WarningsExact identifier
application number: M020
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-053-01499670053011 BOTTLE in 1 CARTON (49967-053-01) / 50 mL in 1 BOTTLE1 bottle2023-07-01NoNoCurrent
49967-053-02499670053021 TUBE in 1 CARTON (49967-053-02) / 15 mL in 1 TUBE1 tube2023-07-01NoNoCurrent
49967-053-03499670053032 mL in 1 PACKET (49967-053-03) 2 ml2023-07-01NoNoCurrent
49967-053-04499670053041 BOTTLE in 1 CARTON (49967-053-04) / 100 mL in 1 BOTTLE1 bottle2025-06-15NoNoCurrent