FDA Label for Dermaka Broad Spectrum Spf-42 Sunscreen Untinted
View Indications, Usage & Precautions
Dermaka Broad Spectrum Spf-42 Sunscreen Untinted Product Label
The following document was submitted to the FDA by the labeler of this product Dermaka Skin Products. 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.
Drug Facts
Active Ingredients
Titanium dioxide 6.00%
Zinc Oxide 11.00%
Purpose
Sunscreen
Uses:
- Helps prevent sunburn.
- higher SPF gives more sunburn protection
- 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 onlynot intended for ingestion.
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 or irritation develops and lasts.
Consult your doctor before use if
Pregnant Or Breastfeeding.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
- Apply liberally 15 minutes before sun exposure.
- Children under 6 months of age: ask a doctor.
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. – 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information:
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Citric Acid, Chamomilla Recutita (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Gleceryl Stearate, Glyceryl Undecylenate, Glyyrrhiza Glabra (Licorice) Extract, Hawthorn Exract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, Sambucus Nigra (Elderberry)Extract, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.
Questions?
(772) 266-3376
Package Labeling:
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