FDA Label for Antioxidant Sunscreen Spf 40
View Indications, Usage & Precautions
Antioxidant Sunscreen Spf 40 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 ingredients | Purpose |
|---|---|
| Octinoxate 7.5% | Sunscreen |
| Zinc Oxide 7.0% | 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.
Directions
- Apply liberally 15 minutes before sun exposure
- Re-apply after 80 minutes of swimming or sweating, anytime after towel drying, or at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Use on children under 6 months of age: consult a doctor.
- 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
Inactive Ingredients
Ascorbic Acid, Ascorbyl Palmitate, Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Ceresin, Chitosan, Cyclomethicone, Diazolidinyl Urea, Disodium EDTA, Laureth-7, Lauryl PEG/PPG-18/18 Methicone, Methylparaben, Phospholipids, Polyacrylamide, Propyl Gallate, Propylene Glycol, Propylparaben, Purified Water, Retinyl Palmitate, Sodium Chloride, Superdioxide Dismutase, Tocopheryl Acetate, Ubiquinone (Co Q-10).
Principal Display Panel - 105 Ml Bottle Label
CITRIX®
VITAMIN C
ANTIOXIDANT SUNSCREEN
BROAD SPECTRUM SPF 40
UVA & UVB Protection
Micronized Zinc Oxide
Water Resistant (80 minutes)
POLYMER MATRIX TECHNOLOGY
Net 3.5 fl. oz. (105 ml)
Topix Pharmaceuticals, Inc. | N. Amityville, NY 11701
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