Label: I-MAX EXCELLENCE- avobenzone octinoxate oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 42952-101-12 - Packager: MAXLIFE USA, 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 7, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STOP USE
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
ALKYL BENZOATE, ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, C12-15 GLYCERYL STEARATE, CETEARYL PHOSPHATE, ETHYLHEXYLGLYCERIN, MAGNESIUM ALUMINUM SILICATE, PHENOXYETHANOL, PROPYLENE GLYCOL, SODIUM HYDROXIDE, STEARETH-20, STEARYL ALCOHOL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, WATER (AQUA).
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INGREDIENTS AND APPEARANCE
I-MAX EXCELLENCE
avobenzone octinoxate oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42952-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL PHOSPHATE (UNII: VT07D6X67O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARETH-20 (UNII: L0Q8IK9E08) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42952-101-12 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/15/2012 Labeler - MAXLIFE USA, INC. (785111431) Registrant - MAXLIFE USA, INC. (785111431) Establishment Name Address ID/FEI Business Operations CUSTOM RESEARCH LABS INC 028611598 manufacture(42952-101)