Label: BROAD SPECTRUM MOISTURIZING SUNSCREEN SPF 30- octinoxate, zinc oxide, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70367-005-01, 70367-005-04 - 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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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Stearyl Alcohol, Cetyl Alcohol, Squalane, Polysorbate 60, Vitamin E Tocopheryl Acetate, Pine Bark Extract, Japanese Green Tea Extract, Rosehips Extract, Licorice Extract, Sodium Edetate, Xanthan Gum, Magnesium Aluminum Silicate, Phenoxyethanol, Ethylhexyiglycerin, Hydroethylacrylate/Sodium Acryloldimethyl Copolymer, Fragrance
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM MOISTURIZING SUNSCREEN SPF 30
octinoxate, zinc oxide, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70367-005 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 ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.2 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 Inactive Ingredients Ingredient Name Strength DIISOPROPYL SEBACATE (UNII: J8T3X564IH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LICORICE (UNII: 61ZBX54883) XANTHAN GUM (UNII: TTV12P4NEE) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) LAURYL LACTATE (UNII: G5SU0BFK7O) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL ALCOHOL (UNII: 936JST6JCN) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70367-005-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 2 NDC:70367-005-01 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)
