ROE wellness spf 50 mineral powder

Manufacturer
Aopline Health Industry Technology (Guangzhou) Co., Ltd.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:51:41

Label at a glance#

ProductROE wellness spf 50 mineral powder
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections

Indications and uses

Uses: Helps prevent sunburn.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 23.9%
Zinc Oxide 24.1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn.

Warnings

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 .

Directions

DOSAGE & ADMINISTRATION 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.

Other Information

OTHER SAFETY INFORMATION

Other Information : Sun alert : Limiting sun exposure , wearing protective clothing , using sunscreens may reduce the risks of skin aging , skin cancer , and other harmful effects of the sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

Keep out of reach of children.

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 .

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs
When using this product keep out of eyes . Rinse with water to remove .

OTC - WHEN USING SECTION

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 .

Do not use

OTC - DO NOT USE SECTION

Do not use on broken or damaged skin .
Stop use and ask a doctor if rash occurs

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82723-003-01

82723-003-0182723-003-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82723-003-01ROE wellness spf 50 mineral powder6 g in 1 BOXPOWDER64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82723-003ROE WELLNESS SPF 50 MINERAL POWDER (SPF 50 MINERAL POWDER) POWDER [AOPLINE HEALTH INDUSTRY TECHNOLOGY (GUANGZHOU) CO., LTD.]41 package rows20250110_f6710e0a-e374-96c8-e053-2995a90a11b6.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82723-00382723-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
2b3c0ceb-3308-b52c-e063-6294a90a39a7f6710e0a-e374-96c8-e053-2995a90a11b62025-01-08WarningsExact identifier
spl id: 2b3c0ceb-3308-b52c-e063-6294a90a39a7
spl set id: f6710e0a-e374-96c8-e053-2995a90a11b6

Reported adverse events (FAERS/openFDA)#

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