Label: MDSOLARSCIENCES SPF 30 MINERAL TINTED- titanium dioxide and zinc oxide cream
- NDC Code(s): 49358-547-01
- 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.
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- 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
- Immeditately 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
- 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
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 Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum ExtractClose
- PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
developed & approved
Water resistant (80 minutes)
Non-comedogenic – won't clog pores
Net Wt. 48 g - 1.7 Oz
- INGREDIENTS AND APPEARANCE
MDSOLARSCIENCES SPF 30 MINERAL TINTED
titanium dioxide and zinc oxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-547 Route of Administration TOPICAL DEA Schedule 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:49358-547-01 1 in 1 CARTON 1 48 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/01/2016 Labeler - MD Solar Sciences (013647301)