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 338 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Strawberry Limoncello SPF 15 Broad Spectrum Lip BalmSTRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222bd6e-59b0-394a-e053-2995a90ae4292023-10-18WarningsExact identifier
application number: M020
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip BalmRASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc2150247-ff7d-9863-e053-2995a90a3f012023-10-18WarningsExact identifier
application number: M020
Key Lime Pie Shake SPF 15 Broad Spectrum Lip BalmKEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc214e5c2-53ea-31bd-e053-2995a90a886a2023-10-18WarningsExact identifier
application number: M020
Summer Sangria SPF 15 Broad Spectrum Lip BalmSUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222cc2d-232c-0f3d-e053-2995a90af79b2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Mineral Sun StickBROAD SPECTRUM SPF 30 MINERAL SUN STICKRaining Rosec2261a55-12e4-9a75-e053-2a95a90a82112023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec238ce45-91d9-e9fa-e053-2a95a90a7d652023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec23d49bd-8447-4920-e053-2a95a90a0a062023-10-18WarningsExact identifier
application number: M020
Tropical Mint Broad Spectrum SPF 15 Lip MoisturizerTROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaef6b419-efac-4e37-e053-2995a90a0d2f2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Cherry Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALMRaining Roseefbd2179-5f6d-a8c6-e053-2a95a90a17e72023-10-18WarningsExact identifier
application number: M020
Vanilla Mint Broad Spectrum SPF 15 Lip MoisturizerVANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf10a007-6597-2231-e053-2995a90a87172023-10-18WarningsExact identifier
application number: M020
Mint Broad Spectrum SPF 15 Lip MoisturizerMINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf471721-54e4-0738-e053-2a95a90a7e122023-10-18WarningsExact identifier
application number: M020
Spearmint SPF 15 Broad Spectrum Lip BalmSPEARMINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9029e6d-7443-efe2-e053-2995a90a81252023-10-18WarningsExact identifier
application number: M020
Watermelon Twist SPF 15 Broad Spectrum Lip BalmWATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0de5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Vanilla Mint SPF 15 Broad Spectrum Lip BalmVANILLA MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9031b15-d2b0-d248-e053-2a95a90a65ff2023-10-18WarningsExact identifier
application number: M020
Cherry SPF 15 Broad Spectrum Lip BalmCHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a7326-aaa4-767b-e053-2995a90adf162023-10-18WarningsExact identifier
application number: M020
Wildberry SPF 15 Broad Spectrum Lip BalmWILDBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903c855-867b-4f14-e053-2a95a90a53332023-10-18WarningsExact identifier
application number: M020
Tropical SPF 15 Broad Spectrum Lip BalmTROPICAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903202b-1dc6-85ad-e053-2995a90a4ab82023-10-18WarningsExact identifier
application number: M020
Pomegranate SPF 15 Broad Spectrum Lip BalmPOMEGRANATE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca901e45d-2ea6-bae8-e053-2a95a90afc982023-10-18WarningsExact identifier
application number: M020
Vanilla SPF 15 Broad Spectrum Lip BalmVANILLA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0dd5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Raspberry SPF 15 Broad Spectrum Lip BalmRASPBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902917c-b8fb-b2d0-e053-2995a90a42db2023-10-18WarningsExact 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