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 213 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melan Antioxidant Body Mist Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMELAN INC.f627b17f-d2dc-47bd-b865-08995995e8612025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.63e078a3-d5df-4458-a745-e306d734e6be2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.90531e8f-15c6-49ac-96a4-3bdfab2bfd9b2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.28db9f44-780f-4cd5-940e-3ee779f382472025-05-20WarningsExact identifier
application number: M020
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
application number: M020
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
application number: M020
Coola Clear California SummersOCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATECOOLA, LLC358009c4-492d-ac03-e063-6294a90af2272025-05-19WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEONESKIN INC.3581f578-e19e-9ace-e063-6294a90acc342025-05-19WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS351251f5-e656-98b6-e063-6394a90ad8052025-05-14WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS35129e6f-c6bd-a9f7-e063-6394a90ab0e42025-05-14WarningsExact identifier
application number: M020
Noevir Raysela UV Shield PrimerZINC OXIDE, OCTINOXATENippon Shikizai, Inc.45030b2f-21cf-4285-af12-87ea8f0b8df72025-05-14WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEONESKIN INC.351d55f6-fcd9-1d47-e063-6294a90a2cf02025-05-14WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350cd329-8fe2-314f-e063-6394a90ac9542025-05-13WarningsExact identifier
application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30ZINC OXIDELancer Skincare LLC522a9158-2fd1-4634-adef-2ba84c86bcd72025-05-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENENavajo Manufacturing Company Inc.33f13aa4-9279-c251-e063-6294a90a2d672025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEAllure Labs34f51ff4-541d-2b2e-e063-6394a90a39da2025-05-12WarningsExact identifier
application number: M020
Bright Guard Natural SPF 30ZINC OXIDERenu Laboratories, LLCe7035fcd-6894-3360-e053-2a95a90a6f1d2025-05-12WarningsExact identifier
application number: M020
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEAllure Labs34f674c1-5d59-915a-e063-6394a90a6c2f2025-05-12WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONEMeaningful Beauty, LLCf59fe019-569b-49ba-accf-fa4d356ce96b2025-05-12WarningsExact 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