NDC | 76159-345-01, 76159-345-02 |
Set ID | 2bee6b87-c889-4ea1-87ad-e28949bcb67a |
Category | HUMAN OTC DRUG LABEL |
Packager | 3LAB, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- Keep out of reach of children
- Directions
- Other Information
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Inactive Ingredients
Water (Aqua/Eau), Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/ PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-15, Polyacrylate-17, Alcohol, Butylene Glycol, Adenosine, Euterpa Oleracea (Acai) Fruit Extract, Portulaca Oleracea Extract, Morus Alba (Mulberry) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Dipotassium Glycyrrhizate, Glyceryl Stearate, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Panthenol, Cetyl Alcohol, Caprylyl Glycol, Tocopheryl Acetate, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Potassium Hydroxide, Disodium EDTA
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DESCRIPTION
This ultimate sun protection cream was created for those who desire a maximum defense against UVA and UVB rays while fighting free radical damage. Using a unique, lightweight formula with special polymer technology, this sunblock helps to prevent sun damage without feeling heavy on the skin. The powerful antioxidants, green tea and acai berry, work to combat the signs of premature aging, such as sun spots and wrinkles, while Vitamin E soothes and hydrates sun exposed skin.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM
homosalate, octisalate, avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76159-345 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ADENOSINE (UNII: K72T3FS567) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PANTHENOL (UNII: WV9CM0O67Z) CETYL ALCOHOL (UNII: 936JST6JCN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76159-345-01 60 mL in 1 TUBE; Type 0: Not a Combination Product 12/19/2017 2 NDC:76159-345-02 10 mL in 1 TUBE; Type 0: Not a Combination Product 12/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/21/2011 Labeler - 3LAB, Inc (162333277) Establishment Name Address ID/FEI Business Operations Englewood Lab, Inc. 080987545 manufacture(76159-345) Establishment Name Address ID/FEI Business Operations Englewood Lab Korea Co., Ltd. 690104005 manufacture(76159-345)