Label: MOISTURE SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68062-9001-1 - 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 September 9, 2021
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- Active Ingredients
- Purpose
- Warnings
- Directions
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Inactive Ingredients
Aqua, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Polyglyceryl-6 Distearate, Glyceryl Stearate, Titanium Dioxide, PEG-100 Stearate, Jojoba Esters, Polyhydroxystearic Acid, Polyglyceryl-3 Beeswax, Disodium EDTA, *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, Ascorbic Acid (Vitamin C),
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INGREDIENTS AND APPEARANCE
MOISTURE SUNSCREEN SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-9001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12.6 mg in 120 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 9 mg in 120 mL Inactive Ingredients Ingredient Name Strength HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERIN (UNII: PDC6A3C0OX) COCONUT OIL (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68062-9001-1 120 mL in 1 TUBE; Type 0: Not a Combination Product 09/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/09/2021 Labeler - Spa de Soleil (874682867) Establishment Name Address ID/FEI Business Operations Spa de Soleil 874682867 manufacture(68062-9001)