ROE WELLNESS SPF 50 MINERAL- spf 50 mineral powder powder

ROE WELLNESS SPF 50 MINERAL by

Drug Labeling and Warnings

ROE WELLNESS SPF 50 MINERAL by is a Otc medication manufactured, distributed, or labeled by Aopline Biotechnology (Guangzhou) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 23.9%
Zinc Oxide 24.1%

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Uses: Helps prevent sunburn.

WARNINGS

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

Immediately after towel drying.
At least every 2 hours.

INDICATIONS & USAGE

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROE WELLNESS SPF 50 MINERAL 
spf 50 mineral powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87283-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.1 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CI 77492 (UNII: EX438O2MRT)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CI 77491 (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
SILICA (UNII: ETJ7Z6XBU4)
CERAMIDE 9 (UNII: 88KCS7120E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87283-003-01	6 g in 1 BOX; Type 0: Not a Combination Product	01/08/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/08/2026

Labeler - Aopline Biotechnology (Guangzhou) Co., Ltd. (514879104)

Registrant - Aopline Biotechnology (Guangzhou) Co., Ltd. (514879104)