FDA.reportPublic FDA data

85448-002 Hand Sunscreen Cream

Manufacturer
Jiangsu Senwo Medical Technology Co., Ltd.
Effective date
2026-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:46

Label at a glance#

ProductHand Sunscreen Cream
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 3%
Octisalate - 5%
Octocrylene - 10%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION


Apply generously and evenly 15 minutes before sun exposure.
Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin agingTo decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Water, Glycerin, Butylocty, Salicylate, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Propanedtiol, Glyceryl StearateCitrate, Cocoglycerides, Isododecane, Cetyl Esters, CetylPhosphate, Diisopropyl Sebacate, IsodecylNeopentanoate, Lauryl, Lactate, Arginine, 1, 2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone,Polymethylsilsesquioxane, Raphanus Sativus (Radish) Seed Oil, Diethylhexyl Syingylidenemalonate, HelianthusAnnuus (Sunflower) Seed Wax, Limnanthes Alba(Meadowfoam) Seed Oil, Acrylates/C10-30 AlkylAcrylateCrosspolymer, Chlorphenesin, Xanthan Gum, Trisodium EthylenediamineDisuccinate, Argania Spinosa KernelOil, Caprylic/Capric Triglyceride, Citrus Nobilis (Mandarin Orange) Peel Oi, Plantago Lanceolata Leaf Extract,Glycine Soja(Soybean) Oil, Tocopherol, Cymbopogon Schoenanthus Oil, Hippopophae Rhamnoides Fruit Oil,ElettariaCardemomum Seed Oi, Eugenia Caryophyllus(Clove)Leaf Oil, Cinnamomum CassiaLeaf Oil, Vanillin,Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Grosso Herb Oil
Other minor components
Butylene Glycol, Cetyl Alcohol Polyether-20, Stearoglycerin, EDTA Disodium, Ethylhexyl Stearate, Cactus Extract,Propylene Glycol, Xanthan Gum, Glycyrhza Root Extract, Oat Bran Extract, Hydroxy Kudzu Root Glycoside, PeonyRoot Extract, Kudzu Extract, Scutellaria Root Extract, Kudzu Glycoside

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128810025929282label.jpg

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85448-00285448-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
GLYCERINPDC6A3C0OXIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CITRUS NOBILIS (MANDARIN ORANGE) PEEL OILNJO720F72RIACT
OCTISALATE4X49Y0596WACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL BEHENATE2712V7RQMHIACT
SALICYLATE MEGLUMINEZ1EQ13H492IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
CETYL ESTERSD072FFP9GUIACT
DIETHANOLAMINE CETYL PHOSPHATE4UG0316V9SIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
LAURYL GLYCOLEMM0U4H102IACT
ARGININE94ZLA3W45FIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
CYMBOPOGON SCHOENANTHUS OILXE7K568ILOIACT
EUGENIA CARYOPHYLLUS (CLOVE) LEAF OILVCA5491KVFIACT
SELENICEREUS GRANDIFLORUS FLOWERII877K4UNRIACT
RAPHANUS SATIVUS VAR. SATIVUS SEEDA94I086Q5EIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
GLYCINE MAX (SOYBEAN) OIL241ATL177AIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
ELETTARIA CARDAMOMUM SEED OILJM0KJ091HZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
LICORICE61ZBX54883IACT
PUERARIA MONTANA VAR. LOBATA ROOTPET93F4I3CIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
EDETATE DISODIUM7FLD91C86KIACT
OAT BRANKQX236OK4UIACT
COCOGLYCERIDESISE9I7DNUGIACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sunscreen CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEJiangsu Senwo Medical Technology Co., Ltd.4e615757-76b1-8f34-e063-6394a90a280a2026-04-01WarningsExact identifier
ndc (package): 85448-002-01
ndc (product): 85448-002
ndc11 (package): 85448000201
spl id: 4e615757-76b2-8f34-e063-6394a90a280a
spl set id: 4e615757-76b1-8f34-e063-6394a90a280a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.