Label: MAXIMUM REPAIR SPF 50 BROAD SPECTRUM- spf 50 cream
- NDC Code(s): 84178-008-01
- Packager: EVI LABS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Directions
- Administration
- Warnings
- Keep out of reach of children's
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Inactive Ingredients
Water purified, Aloe Barbadensis Leaf (aloe Vera Gel) Juice, Glycerin, Cetearyl Alcohol, Zemea-Propylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Beeswax, Jojoba Oil, Organic (Simmondsia Chinensis Seed Oil), Dicaprylyl Carbonate, Isopropyl Myristate, Stearyl Alcohol, Acrylate Copolymer, Dimethicone Fluido, Polysorbate-20, Vitamin E (Tocopheryl Acetate), Phenoxyethanol SA, Carbomer, Butyloctyl Salicylate, Hydrolyzed Collagen, Hydrolyzed Jojoba Protein, Methyl Methacrylate Crosspolymer, Vitamin B3 (Niacinamide), Sodium EDTA, Sodium Ascorbyl Phosphate (Vitamin C), Xanthan Gum, Fragrance and Ehylhexylglyrecin.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM REPAIR SPF 50 BROAD SPECTRUM
spf 50 creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84178-008 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.8 g in 48 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.4 g in 48 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.44 g in 48 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.88 g in 48 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) 0.96 g in 48 g STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 0.72 g in 48 g ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.96 g in 48 g GLYCERIN (UNII: PDC6A3C0OX) 1.44 g in 48 g ALOE (UNII: V5VD430YW9) 2.4 g in 48 g SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) 0.096 g in 48 g FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0) 0.48 g in 48 g CUCUMBER JUICE (UNII: 61845009SP) 0.96 g in 48 g POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.144 g in 48 g EDETATE DISODIUM (UNII: 7FLD91C86K) 0.096 g in 48 g HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.96 g in 48 g MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 0.72 g in 48 g DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 0.01 g in 48 g CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.44 g in 48 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.44 g in 48 g ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.24 g in 48 g SODIUM BENZOATE (UNII: OJ245FE5EU) 0.144 g in 48 g PANTHENOL (UNII: WV9CM0O67Z) 0.12 g in 48 g .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.48 g in 48 g NIACINAMIDE (UNII: 25X51I8RD4) 0.24 g in 48 g COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2) 0.24 g in 48 g WATER (UNII: 059QF0KO0R) 20.39 g in 48 g DIMETHICONE 20 (UNII: H8YMB5QY0D) 0.48 g in 48 g POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.24 g in 48 g HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62) 0.24 g in 48 g XANTHAN GUM (UNII: TTV12P4NEE) 0.096 g in 48 g PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I) 1.032 g in 48 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.576 g in 48 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84178-008-01 1 in 1 BOX 10/09/2024 1 48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/09/2024 Labeler - EVI LABS (123617598) Establishment Name Address ID/FEI Business Operations EVI LABS 123617598 manufacture(84178-008)
