FDA.reportPublic FDA data

Hand Sunscreen Cream

Product NDC
85448-002
11-digit product format
854480002
Labeler code
85448
Product ID
85448-002_4e615757-76b2-8f34-e063-6394a90a280a
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangsu Senwo Medical Technology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
.05; .1; .03 g/mL; g/mL; g/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
Hand Sunscreen Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE.05 g/mL
OCTOCRYLENE.1 g/mL
AVOBENZONE.03 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e615757-76b1-8f34-e063-6394a90a280aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85448-002-01Hand Sunscreen Cream44 mL in 1 BOTTLECREAM441

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 310 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry SkinOCTINOXATEL'Oreal USA Products Inca45fef28-5dde-48b2-b7c0-ede694f4c32b2023-12-30WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC34f0c2c9-a5bc-4b25-bfc1-336dcbb353e42023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incfb9daea3-c249-417c-ad34-3e89f31185592023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle ReducingAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc3f58b258-b954-41f0-93ad-f6c9fe25718d2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d32023-12-30WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incbf0e22df-4043-407f-a930-29595da1bdf62023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 MInutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc04fd0839-5046-4633-a919-6b7b6bea4f3e2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions Super Fluid Daily UV Defense Broad Spectrum SPF 50 plus Sunscreen Antipollution Lightweight FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.ed138c48-d542-4522-a23c-1b586aad11272023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin TypesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incd1a8c8d2-59d2-4389-9369-5f9b053a956e2023-12-30WarningsExact identifier
application number: M020
Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc43041108-6adb-4dd3-a75f-87f5d643c7942023-12-30WarningsExact identifier
application number: M020
Lancome Paris Bienfait MultiVital Eye Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc449a6027-4d0d-40e1-af58-3553071d6fdf2023-12-30WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baff2dfe-fd0b-0709-e053-2a95a90a431b2023-12-29WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb013e70-f081-f8f2-e053-2995a90a19812023-12-29WarningsExact identifier
application number: M020
Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skinAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1c83726b-f8ff-48d5-bf30-bc75e3fb149d2023-12-29WarningsExact identifier
application number: M020
LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20OCTINOXATEL'Oreal USA Products Inccf39375c-de44-47de-bf15-fce4dfad8c742023-12-29WarningsExact identifier
application number: M020
Loreal Paris Age Perfect Radiant Serum foundation SPF 50HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06a94c28-bfb7-4842-a463-459205477cd82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PEACHES N SOLZINC OXIDE SUNSCREENBentley Laboratories, LLCe7c9c914-9972-4b55-a49d-cbc8ce0756472023-12-29WarningsExact identifier
application number: M020
LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25AVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8840da10-63cb-47ea-ad46-1ae6df1639e82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PINK SUNRISEZINC OXIDE SUNSCREENBentley Laboratories, LLC289fb410-7884-4bc4-a25b-963de1cc3a702023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 SunscreenOCTINOXATEL'Oreal USA Products Inc82a6fbba-f0d4-475f-9ba7-615118eed70d2023-12-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85448-002-018544800020144 mL in 1 BOTTLE (85448-002-01) 44 ml2026-04-01NoNoCurrent