Label: MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49358-554-01 - Packager: MDSolarSciences
- 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.
Drug Label Information
Updated September 26, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
Shake well. Rub in well.
- Apply liberally 15 minutes before sun exposure
- Reapply:
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- After 80 minutes of swimming or sweating
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- Immediately after towel drying
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- At least every 2 hours
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- Children under 6 months: Ask a doctor
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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:
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- Limit time in the sun, especially from 10a.m. – 2p.m.
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- Wear long-sleeved shirts, pants, hats and sunglasses
- Other Information
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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 (GreenTea) Extract, Vaccinium Macrocarpon (Cranbery) Fruit Extract, Punica Granatum (Pomegranate) Extract
- PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
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INGREDIENTS AND APPEARANCE
MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-554 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 2.7 g in 35 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 1.3 g in 35 g Inactive Ingredients Ingredient Name Strength Dimethicone (UNII: 92RU3N3Y1O) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Silicon Dioxide (UNII: ETJ7Z6XBU4) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYSILICONE-15 (UNII: F8DRP5BB29) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) FERRIC OXIDE RED (UNII: 1K09F3G675) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CRANBERRY (UNII: 0MVO31Q3QS) POMEGRANATE JUICE (UNII: 99S671U9KB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-554-01 1 in 1 CARTON 01/01/2016 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 - MDSolarSciences (013647301)
