FDA.reportPublic FDA data

84938-011 Sunscreen Lotion

Manufacturer
Foshan Sugar Max Cosmetics CO.,Ltd
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:25:55

Label at a glance#

ProductSunscreen Lotion118ml
Active ingredientTITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%,Titanium Dioxide 6%, Homosalate 14%,Octisalate 5%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Uses 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. lf product is swallowed get medical help or contact a Poison Control Center right away.
May stain some fabrics.

DOSAGE & ADMINISTRATION SECTION

Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating"lmmediately after towel drying " at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skinaging. To 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 shirtspants, hats,and sunglasses children under 6 months.Ask a doctor

INACTIVE INGREDIENT SECTION

Aqua (Water)
Caprylic/Capric Triglyceride
Dimethicone
Isohexadecane
Cetearyl Alcohol
Glyceryl Stearate Citrate
Triethoxycaprylylsilane
Stearic Acid
Aluminum Hydroxide
Glycerin
Butylene Glycol
Sodium Hyaluronate (Hydrolyzed)
Ammonium Acryloyldimethyltaurate/VP Copolymer
Phenoxyethanol
Ethylhexyl Glycerin
Tocopheryl Acetate
Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label4label4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130644818950012GTIN-13: 0644818950012
EAN-13: 0644818950012
GTIN-12: 644818950012
UPC-A: 644818950012
GTIN storage (14 digits): 00644818950012		label4.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84938-011-01Sunscreen Lotion118ml118 mL in 1 BOTTLELOTION1181

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84938-01184938-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
XANTHAN GUMTTV12P4NEEIACT
CETEARYL ALCOHOL2DMT128M1SIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
HOMOSALATEV06SV4M95SACTIB
STEARIC ACID4ELV7Z65APIACT
ISOHEXADECANE918X1OUF1EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
SODIUM HYALURONATEYSE9PPT4THIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
AQUA059QF0KO0RIACT

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
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
ndc (package): 84938-011-01
ndc (product): 84938-011
ndc11 (package): 84938001101
spl id: 4620c41a-2189-00f5-e063-6394a90a613c
spl set id: 4620c41a-2188-00f5-e063-6394a90a613c

Reported adverse events (FAERS/openFDA)#

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