Label: MDSOLARSCIENCES SPF 50 MINERAL- titanium dioxide and zinc oxide cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 22, 2013
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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.
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 10a.m. – 2p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
- Other information
Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Silica, Butyloctyl Salicylate, Polysilicone-15, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Tetrahexyldecyl Ascorbate, Camellia Sinensis Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Extract
PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
Developed & Approved by Dermatologists
water resistant (80 minutes) / non-comedogenic
suited for all skin types including acne & rosacea
formulated without fragrance
Net Wt. 48 g - 1.7 Oz.
INGREDIENTS AND APPEARANCE
MDSOLARSCIENCES SPF 50 MINERAL
titanium dioxide and zinc oxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-546 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 15 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 170 mg in 1 g Inactive Ingredients Ingredient Name Strength Dimethicone (UNII: 92RU3N3Y1O) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Glyceryl Isostearate (UNII: HYE7O27HAO) Silicon Dioxide (UNII: ETJ7Z6XBU4) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Polysilicone-15 (UNII: F8DRP5BB29) PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794) Triethoxycaprylylsilane (UNII: LDC331P08E) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Green Tea Leaf (UNII: W2ZU1RY8B0) Cranberry (UNII: 0MVO31Q3QS) Punica Granatum Root Bark (UNII: CLV24I3T1D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-546-01 1 in 1 CARTON 1 48 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)