ROE WELLNESS SPF 50 MINERAL POWDER- spf 50 mineral powder powder

ROE wellness spf 50 mineral powder by

Drug Labeling and Warnings

ROE wellness spf 50 mineral powder by is a Otc medication manufactured, distributed, or labeled by Aopline Health Industry Technology (Guangzhou) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 23.9%
Zinc Oxide 24.1%

Purpose

Sunscreen

Uses

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 .

Directions

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 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 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.

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

Stop use

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

WHEN USING

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

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

Package Label

82723-003-01

INGREDIENTS AND APPEARANCE

ROE WELLNESS SPF 50 MINERAL POWDER 
spf 50 mineral powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82723-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CERAMIDE NP (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER DISPERSION (2:1; 600000 MW 30% AQUEOUS) (UNII: 3EW60Z566Z)
.ALPHA.-TOCOPHEROL CALCIUM SUCCINATE, DL- (UNII: H5A1374A6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82723-003-01	6 g in 1 BOX; Type 0: Not a Combination Product	05/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/07/2022

Labeler - Aopline Health Industry Technology (Guangzhou) Co., Ltd. (715076108)

Establishment
Name	Address	ID/FEI	Business Operations
Aopline Health Industry Technology (Guangzhou) Co., Ltd.		715076108	manufacture(82723-003)