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 232 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d0856cf-d3da-5a77-e063-6294a90ad5b42025-01-31WarningsExact identifier
application number: M020
FRE PROTECT BODY Ultra-Light Gel Cream SPF 50ZINC OXIDEPeer Pharm Ltd.2cd83c55-851c-089e-e063-6294a90ad6bc2025-01-30WarningsExact identifier
application number: M020
FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50ZINC OXIDEPeer Pharm Ltd.2cd958a3-bad6-725e-e063-6294a90a85782025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30ZINC OXIDEPeer Pharm Ltd.2cd77d62-77df-f3a9-e063-6394a90ad57d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30ZINC OXIDEPeer Pharm Ltd.2caf3b6b-3a05-b24a-e063-6394a90a47992025-01-30WarningsExact identifier
application number: M020
Jil Goorman Skincare Sun Guard SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY9a088bed-3b85-4bf5-923b-4c99eb904a8d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30ZINC OXIDEPeer Pharm Ltd.2baf0278-7e13-4db0-e063-6294a90ae9de2025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.08a175ae-2307-ef8d-e063-6394a90ad2342025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Super Shield Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc08b7bcfd-0c7c-a14f-e063-6294a90a77972025-01-30WarningsExact identifier
application number: M020
Salt and Stone Sunscreen Lip Balm SPF 30ZINC OXIDESalt and Stone LLCb555aa10-1547-63cc-e053-2995a90ad20d2025-01-30WarningsExact identifier
application number: M020
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
application number: M020
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
application number: M020
Perfect Sunscreen Tinted Mineral SPF50ZINC OXIDEBluemercury, Inc.4c978154-679f-472a-95ab-56878c5c70cd2025-01-29WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
application number: M020
SEAWEED BATH CO. Super Sheer Face Serum SPF-50ZINC OXIDEThe Seaweed Bath Co.a45b46f9-681f-4a8d-b561-165b995ccf802025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc62961-dcef-d7db-e063-6394a90a9ebd2025-01-28WarningsExact identifier
application number: M020
Every Sun Day Ultra-Sheer Priming Sunscreen StickAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEHave & Be Co., Ltd.2b53aa68-9c05-1682-e063-6294a90a968c2025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc73c4f-30ea-0a51-e063-6394a90ac9a42025-01-28WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc84aba-006b-a78e-e063-6294a90ae0402025-01-28WarningsExact 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