TOPIX MINERAL FINISHING SUNSCREEN SPF 30- zinc oxide powder

Topix Mineral Finishing Sunscreen by

Drug Labeling and Warnings

Topix Mineral Finishing Sunscreen by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc, Topiderm, Inc., Aopline Health Industry Technology (Guangzhou) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc Oxide 24.7%

Purpose

Sunscreen

Uses

• Helps prevent sunburn If 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.

Keep 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 at least every 2 hours

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad 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

Silica, 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 - 5 g Bottle Box

MINERAL POWDER

BRUSH-ON
SUNSCREEN
SPF
30

SUN PROTECTION
+ OIL CONTROL

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

BROAD SPECTRUM SPF 30

Net 0.16 oz. (5 g)

INGREDIENTS AND APPEARANCE

TOPIX MINERAL FINISHING SUNSCREEN  SPF 30
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	241 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CERAMIDE 1 (UNII: 5THT33P7X7)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-206-01	1 in 1 BOX	02/26/2024
1		5 g in 1 BOTTLE, WITH APPLICATOR; 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	02/26/2024

Labeler - Topiderm, Inc (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Aopline Health Industry Technology (Guangzhou) Co., Ltd.		715076108	MANUFACTURE(51326-206)