FDA Label for Replenix Sheer Spf 50
View Indications, Usage & Precautions
Replenix Sheer 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
- 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 10a.m.-2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
Otc - Purpose
Active ingredient | Purpose |
---|---|
Zinc Oxide 16.5% | Sunscreen |
Titanium Dioxide 2.3% | 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 and spread evenly by hand 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
Acrylates Crosspolymer-4, Ascorbic Acid, Biotin, Butyrospermum Parkii Butter, Camellia Sinensis Leaf (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclomethicone, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Hexyl Laurate, Isododecane, Lauryl PEG/PPG-18/18 Methicone, Lecithin, PEG-10 Dimethicone, Phenoxyethanol, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polysilicone-11, Potassium Cetyl Phosphate, Potassium Hydroxide, Purified Water, Resveratrol, Stearic Acid, Ubiquinone (Coenzyme Q-10), Retinyl Palimtate, Xanthan Gum.
Principal Display Panel - 60 G Bottle Label
REPLENiX®
SHEER PHYSICAL
SUNSCREEN
SPF
50+
CREAM
UVA UVB
BROAD SPECTRUM SPF 50+
- Zinc Oxide 13.75%
- Green Tea Polyphenols
- Resveratrol
- Vitamin C
- Emblica
- CoQ10
Net 2 fl. oz. (60 ml)
Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701
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