Label: MDSOLARSCIENCES SPF 50 MINERAL- titanium dioxide and zinc oxide lotion
- NDC Code(s): 49358-548-01
- Packager: MD Solar Sciences
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Shake well. Rub in well.
- Apply liberally 15 minutes before sun exposure
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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 sunlight
- May stain some fabrics
- You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
- Inactive ingredients
Water, Dimethicone, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Octyldodecanol, Quaternium-90 Bentonite, Propylene Carbonate, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Polysilicone-15, PEG-10 Dimethicone, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Extract, Tetrahexyldecyl Ascorbate, Magnesium Aluminum Silicate, Sodium Chloride, Sodium Citrate, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Caprylhydroxamic acid, Caprylyl Glycol, GlycerinClose
- PRINCIPAL DISPLAY PANEL - 78 g Tube Carton
for Face & Body
Developed & Approved by Dermatologists
water resistant (80 minutes) / non-comedogenic
silky smooth and moisturizing
suited for all ages & skin types
formulated without fragrance
Net Wt. 78 g - 2.75 Oz.
- INGREDIENTS AND APPEARANCE
MDSOLARSCIENCES SPF 50 MINERAL
titanium dioxide and zinc oxide lotion
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49358-548 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 30 mg in 1 g Zinc Oxide (Zinc Oxide) Zinc Oxide 150 mg in 1 g Inactive Ingredients Ingredient Name Strength Water Dimethicone Octyldodecanol Propylene Carbonate Butyloctyl Salicylate Polysilicone-15 Green Tea Leaf Cranberry Punica Granatum Root Bark Tetrahexyldecyl Ascorbate Magnesium Aluminum Silicate Sodium Chloride Sodium Citrate Hyaluronate Sodium Aloe Vera Leaf Chamomile Caprylhydroxamic acid Caprylyl Glycol Glycerin Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-548-01 1 in 1 CARTON 1 78 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 02/01/2013 Labeler - MD Solar Sciences (013647301)