FDA Label for Essential Moisturizing Sunscreen
View Indications, Usage & Precautions
Essential Moisturizing Sunscreen 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 ingredient | Purpose |
|---|---|
| Zinc Oxide 14.8% | Sunscreen |
| Octinoxate 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, Diethylhexyl Succinate, Octyldodecyl Neopentanoate, Cetearyl Glucoside, Cetyl Ethylhexanoate, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Xanthan Gum, Butylene Glycol, Triethoxycaprylylsilane, Oleth-3 Phosphate, Ethylhexyl Stearate, Dimethicone, Sucrose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-7 Trimethylolpropane Coconut Ether, Panthenol, Phenoxyethanol, Disodium EDTA.
Principal Display Panel - 63 G Bottle Label
REPLENiX®
SUNSCREEN
ESSENTIAL
MOISTURIZING
SPF 50
14.8% Micronized Zinc Oxide
Hydrating Hyaluronic Acid
Quick-absorbing Application
BROAD SPECTRUM UVA/UVB SPF 50
Net wt. 2.22 oz. (63 g)
TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701
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