SPF 50 MINERAL POWDER SUNSCREEN- titanium dioxide, zinc oxide powder

spf 50 mineral powder sunscreen by

Drug Labeling and Warnings

spf 50 mineral powder sunscreen by is a Otc medication manufactured, distributed, or labeled by Smalls Brand LLC DBA Roe Wellness. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Titanium DIoxide 23.9%

Zinc Oxide 24.1 %

Purpose: Sunscreen

PURPOSE

Uses:

• Helps prevent sunburn

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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warning:

• For external use only. Do not use on broken or damaged skin
• When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & 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

INACTIVE INGREDIENT

Inactive ingredients: Silca, 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

roe wellness

spf 50 mineral powder

borad spectrum

0.21 oz 6g

INGREDIENTS AND APPEARANCE

SPF 50 MINERAL POWDER SUNSCREEN 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83369-001
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
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CERAMIDE 1 (UNII: 5THT33P7X7)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83369-001-01	6 g in 1 CARTON; Type 0: Not a Combination Product	04/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	04/13/2023

Labeler - Smalls Brand LLC DBA Roe Wellness (058449263)