Label: PHARMASKINCARE SOLAR-C MOISTURIZER SPF 30- titanium dioxide lotion
- NDC Code(s): 68062-9099-1
- Packager: Spa de Soleil
- 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 December 27, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Warnings
- For external use only.
- Do not use on broken or damaged skin
- When using this product, keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor is rash or irritation occurs or lasts.
- If swallowed, seek medical help or contact a poison control center right away.
- Keep out of reach of children.
- Directions
- Other Information
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Uses:
Helps prevent sunburn. Higher SPF gives more sunburn protection. Designed for skin highly sensitive to sunburn. If used as directed with other sun protection measures (see Sun Alert) decreases the risk of skin cancer and early skin aging caused by the sun.
Sun Alert: Spending time in the use increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures such as limited time in the sun, especially from 10 a.m. to 2 p.m. Wear long pants, hats, sunglasses, and long-sleeve shirts.
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Inactive Ingredients:
Water, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Jojoba Esters, Polyhydroxystearic Acid, Carbomer, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Benzyl Alcohol, Disodium EDTA, Dehydroacetic Acid
- Warning
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHARMASKINCARE SOLAR-C MOISTURIZER SPF 30
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-9099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.2625 mg in 2.5 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) SAFFLOWER OIL (UNII: 65UEH262IS) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68062-9099-1 120 mL in 1 TUBE; Type 0: Not a Combination Product 10/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/10/2017 Labeler - Spa de Soleil (874682867) Establishment Name Address ID/FEI Business Operations Spa de Soleil 874682867 manufacture(68062-9099)
