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 331 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0f32e-4b19-7a62-e063-6394a90af1b12023-10-30WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5e5777c-2f67-14ed-e053-2a95a90a58a52023-10-30WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc08fb4748-d22d-35af-e063-6394a90a08272023-10-30WarningsExact identifier
application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.d177b085-2bbd-49c1-b02b-a7b8d8ee04682023-10-28WarningsExact identifier
application number: M020
Live Tinted Hueguard 3-in1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.cfceaf45-bab5-6858-e053-2a95a90a6be12023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Hueguard Invisible Sunscreen Stick Broad Spectrum SPF 50 Water Resistant 80 MinsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELive Tinted, Inc.8e4d7c84-5acb-4857-860d-bf6837e4901e2023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.7bceeb0e-b557-438c-88ac-0148f6eb1b4d2023-10-28WarningsExact identifier
application number: M020
Green Defense daily mineral sunscreen Broad Spectrum SPF 30ZINC OXIDEFarmacy Beauty LLCd1ae2696-fd1b-4422-a8e0-5209aeeb97eb2023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Glow-up Hyperpigmentation EssentialsZINC OXIDELive Tinted, Inc.ef06c1eb-6ce3-4b1b-8a7d-3e29ae1728442023-10-28WarningsExact identifier
application number: M020
SPF Elio Drops 30 SheerZINC OXIDEAllure Labs Inc08c9fc56-7d4f-ebc5-e063-6294a90a53172023-10-28WarningsExact identifier
application number: M020
SPF Elio Drops 30 GlowZINC OXIDEAllure Labs Inc08cbf8d6-8c27-1567-e063-6394a90a932e2023-10-28WarningsExact identifier
application number: M020
RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skinAVOBENZONE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCd1ca8372-28a0-41e1-b92a-913fc09f71562023-10-27WarningsExact identifier
application number: M020
Vivier Sheer SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
application number: M020
Vivier Sheer SPF 45ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATEVivier Pharma, Inc.c057138a-1111-4e7c-b94d-2ccd6bc3963c2023-10-27WarningsExact identifier
application number: M020
360 by QUR Spanish lime lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb3347-7498-3d7a-e053-2995a90a4b122023-10-26WarningsExact identifier
application number: M020
360 by QUR Vanilla lace lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb4c53-adaa-3a8a-e053-2a95a90ae93a2023-10-26WarningsExact identifier
application number: M020
360 by QUR Watercress mint lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb7413-c074-a2d7-e053-2a95a90ac5cb2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-cherry vanillaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCc827c6b4-c6d7-4585-b615-419db9520e7c2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-citrusHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLC2f20ee7e-3897-4263-b965-5155d89bfb5e2023-10-26WarningsExact 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