Label: MALIN AND GOETZ SPF 15 FACE MOISTURIZER- octinoxate, octisalate, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53634-152-01 - Packager: Malin & Goetz Inc
- Category: HUMAN OTC DRUG LABEL
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 November 2, 2012
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ACTIVE INGREDIENT
Active ingredients purpose
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 2% Sunscreen
Uses
For skin highly sensitive for sunburn
helps prevent sunburn
higher SPF gives more sunburn protection
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.Directions
Apply liberally before sun exposure. Apply and reapply as directed to avoid lowering protection.
Reapply at least every 2 hours. Children under 6 months: Ask a doctorWater (Aqua), Octyl Dodecyl Neopentanoate, Isocetyl stearate, glycerin, cetyl alcohol, glyceryl stearate, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (olive) Fruit oil, Butyrospermum Parkii (Shea butter), Ormenis Multicaulis, Tocopheryl Acetate, Butylene Glycol, Camellia Oleifera Leaf Extract, Magnesium Ascorbyl Phosphate, Cyano-cobalamin, Cholecalciferol, Retinyl Palmitate, C13-C16 Isoparaffin, C12-C14 Isoparaffin, C13-C15 Alkane, Titanium Dioxide, Polysorbate 80, Carbomer, Triethanolamine, phenoxyethanol, Sodium Dehydroacetate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MALIN AND GOETZ SPF 15 FACE MOISTURIZER
octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-152 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOCETYL STEARATE (UNII: 3RJ7186O9W) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) AVOCADO OIL (UNII: 6VNO72PFC1) OLIVE OIL (UNII: 6UYK2W1W1E) SHEA BUTTER (UNII: K49155WL9Y) CLADANTHUS MIXTUS FLOWER VOLATILE OIL (UNII: RAY2FRM711) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) CHOLECALCIFEROL (UNII: 1C6V77QF41) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) C13-16 ISOPARAFFIN (UNII: LED42LZG6O) C13-15 ALKANE (UNII: 114P5I43UJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOMER 934 (UNII: Z135WT9208) trolamine (UNII: 9O3K93S3TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53634-152-01 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/02/2012 Labeler - Malin & Goetz Inc (138615930) Registrant - Malin & Goetz Inc (138615930) Establishment Name Address ID/FEI Business Operations D'ARCY ACQUISITION, LLC 101381952 manufacture(53634-152)