Label: OIL FREE MATTE SUNSCREEN SPF 30, - ZINC OXIDE, OCTINOXATE, OCTISALATE, OXYBENZONE- zinc oxide, octinoxate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70367-007-01, 70367-007-04 - Packager: Only Yourx, Inc.
- 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 January 23, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
SLauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Cetearyl Alcohol, Ceteareth-20, Cetyl Octanoate, Glyerin, Stearyl Alcohol, Cetyl Alcohol, Boron Nitride, Nylon 12, Vitamin E Tocopheryl Acetate, Allantoin, Alpha-Bisabolol, Pine Bark Extract, Green Tea Extract, Licorice Extract, Rosehips Extract, Passion Flower Extract, Butylene Glycol, Disodium EDTA, Xanthan Gum, Magnesium Aluminum Silicate, Triethoxycaprylsilane, Laureth-7, Ethylhexylglycerin, Phenoxyethanol, Polyacrylamide/C13-14 Isoparaffin
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OIL FREE MATTE SUNSCREEN SPF 30, - ZINC OXIDE, OCTINOXATE, OCTISALATE, OXYBENZONE
zinc oxide, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70367-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.75 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.7 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.2 g in 100 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LICORICE (UNII: 61ZBX54883) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) LAURYL LACTATE (UNII: G5SU0BFK7O) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) XANTHAN GUM (UNII: TTV12P4NEE) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70367-007-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 2 NDC:70367-007-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/26/2014 Labeler - Only Yourx, Inc. (089207519)
