MINERAL SUNSCREEN  SPF 50- zinc oxide titanium dioxide powder 
Topiderm, Inc.

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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Mineral Sunscreen
SPF 50

Drug Facts

Active ingredientsPurpose
Zinc Oxide 24%Sunscreen
Titanium Dioxide 22.5%Sunscreen

Uses

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

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:

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)

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton
MINERAL SUNSCREEN   SPF 50
zinc oxide titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE240 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE225 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-125-051 in 1 CARTON10/14/2020
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/14/2020
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-125)

Revised: 3/2023
Document Id: 13426b29-07f0-45ab-bed0-4af45356f094
Set id: 3a637542-0f79-47ae-815d-84d0036c737a
Version: 1
Effective Time: 20230317
 
Topiderm, Inc.