Roe Wellness Powder sunscreen

SPF 50 MINERAL POWDER SUNSCREEN- titanium dioxide, zinc oxide powder
Smalls Brand LLC DBA Roe Wellness

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients:

Titanium DIoxide 23.9%

Zinc Oxide 24.1 %

Purpose: Sunscreen

Uses:

Helps prevent sunburn

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

Stop use and ask a doctor if rash occurs

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.

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 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

roe wellness

spf 50 mineral powder

borad spectrum

0.21 oz 6g

spf powder carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Smalls Brand LLC DBA Roe Wellness (058449263)