NDC | 70367-007-01, 70367-007-04 |
Set ID | 76444f6a-1d87-44cc-e053-2a91aa0a43d6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Only Yourx, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- PURPOSE
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
-
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
-
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)