FDA Label for Tinted Mineral Sunscreen Spf 50

View Indications, Usage & Precautions

Tinted Mineral Sunscreen Spf 50 Product Label

The following document was submitted to the FDA by the labeler of this product Topiderm, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredientPurpose
Zinc Oxide 11%Sunscreen
Titanium Dioxide 7.5%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.


Otc - When Using



When using this product keep out of eyes, rinse with water to remove.


Otc - Stop Use



Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


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 and other sunscreen measures including:

  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Directions



  • Apply liberally to face and neck and spread evenly 15 minutes before sun exposure
  • Re-apply after swimming, excessive perspiring, or anytime after towel drying
  • Use a water resistant sunscreen if swimming or sweating
  • Use on children under 6 months of age: consult a doctor.

Inactive Ingredients



Purified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.


Principal Display Panel - 99 G Bottle Label



COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

MULTI-TASKING

Mineral
Lightly Tinted
Antioxidant
Sunscreen
SPF 50+

Broad Spectrum SPF 50+
Water Resistant 40 minutes

Net wt. 3.5 oz. (99 g)

Available
Custom Branded
800.445.2595
[email protected]


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