MINERAL SUNSCREEN SPF 50- zinc oxide titanium dioxide powder

Mineral Sunscreen by

Drug Labeling and Warnings

Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Prisha Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Zinc Oxide 24%	Sunscreen
Titanium Dioxide 22.5%	Sunscreen

Uses

• Helps prevent sunburnIf used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keeo out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply atleast every 2 hours
• Sun Protection Measures

Spending time in the sun increases your risk of skin can cer and early skin aging. To decrease this risk, regularly use a sunscreen with a broa spectrum SPF of 15 or higher & other sunscreen measures including:

• Limit time in the sun, especially from 10a.m.-2p.m.
• Wear long-sleeve shirts, pants, hats, & sunglasses
• Children under 6 months of age: Ask a doctor.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Mica, Silica, Caprrylic/Capric Triglyceride, Lauroyl Lusine, Potassium Sorbate, Sodium Benzoate, Undecylenoyl Glycine, Capryloyl Glyccine. Camellia Sinensis Polyphenols, Caffeine, Resveratrol, Tocpheryl Acetatte, Carthamus Tinctorius (Safflower) Seed Oil, Cam llia Sinesis Leaf Extract, Chammomilla Recutita (Matricaria) Flower Extract, Iron Oxides (CI 77489, CI 77492)

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

MINERAL POWDER
UVA/UVB
BROAD
SPECTRUM
SPF
50

SUN PROTECTION
+ OIL CONTROL

Protects against visible aging
Sets makeup and reduces shine
Translucent color blurs imperfections

BROAD SPECTRUM SPF 50

Net wt. 0.14 oz. (4 g)

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN  SPF 50
zinc oxide titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	240 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	225 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LAUROYL LYSINE (UNII: 113171Q70B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAFFEINE (UNII: 3G6A5W338E)
RESVERATROL (UNII: Q369O8926L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHAMOMILE (UNII: FGL3685T2X)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-125-05	1 in 1 CARTON	10/14/2020
1		4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	10/14/2020

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Prisha Cosmetics, Inc		192609902	MANUFACTURE(51326-125)