FDA.reportPublic FDA data

ROE WELLNESS SPF 50 MINERAL

Manufacturer
Aopline Biotechnology (Guangzhou) Co., Ltd.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:32:01

Label at a glance#

ProductROE WELLNESS SPF 50 MINERAL
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 23.9%
Zinc Oxide 24.1%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Uses: Helps prevent sunburn.

WARNINGS SECTION

For external use only .
Do not use on broken or damaged skin .
Stop use and ask a doctor if rash occurs
When using this product keep out of eyes . Rinse with water to remove .
Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

DOSAGE & ADMINISTRATION SECTION

Immediately after towel drying.
At least every 2 hours.

INDICATIONS & USAGE SECTION

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin.
Reapply:
After 80 minutes of swimming or sweating.
Immediately after towel drying.
At least every 2 hours.
Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Slica , Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850038901059GTIN-13: 0850038901059
EAN-13: 0850038901059
GTIN-12: 850038901059
UPC-A: 850038901059
GTIN storage (14 digits): 00850038901059		87283-003-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87283-003-01ROE WELLNESS SPF 50 MINERAL6 g in 1 BOXPOWDER61

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87283-00387283-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CI 77492EX438O2MRTIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CI 774911K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIB
MICAV8A1AW0880IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
SILICAETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CERAMIDE 988KCS7120EIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
ndc (package): 87283-003-01
ndc (product): 87283-003
ndc11 (package): 87283000301
spl id: 47dc8155-4abc-4bb7-e063-6294a90af1ad
spl set id: 47dc8155-4abb-4bb7-e063-6294a90af1ad

Reported adverse events (FAERS/openFDA)#

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