Label: NUTRASCREEN COLOR BALANCED- zinc oxide lotion
- NDC Code(s): 81537-104-02
- Packager: DMK - Danne Montague King
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DESCRIPTION
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
NUTRASCREEN COLOR BALANCED
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81537-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20.24 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 5.56 g in 100 mL SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) 0.78 g in 100 mL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 0.05 g in 100 mL FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.4875 g in 100 mL FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.19 g in 100 mL POLYGONUM AVICULARE WHOLE (UNII: M990N03611) 0.01 g in 100 mL POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX) 3.75 g in 100 mL CYCLOMETHICONE 6 (UNII: XHK3U310BA) 2 g in 100 mL ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z) 0.0025 g in 100 mL FERRIC OXIDE RED (UNII: 1K09F3G675) 0.1463 g in 100 mL PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 0.325 g in 100 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.002 g in 100 mL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) 2.3 g in 100 mL VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) 1.3 g in 100 mL WATER (UNII: 059QF0KO0R) 37.8875 g in 100 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 0.975 g in 100 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.002 g in 100 mL DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 9 g in 100 mL POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 4 g in 100 mL TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) 1.9 g in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 1.125 g in 100 mL PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.75 g in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.67 g in 100 mL ISOHEXADECANE (UNII: 918X1OUF1E) 0.65 g in 100 mL POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.52 g in 100 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.125 g in 100 mL GALACTOARABINAN (UNII: SL4SX1O487) 0.1037 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.111 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 3.4125 g in 100 mL Product Characteristics Color brown (Opaque Orange-Brown Lotion) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81537-104-02 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/15/2022 Labeler - DMK - Danne Montague King (624242264) Registrant - DMK - Danne Montague King (624242264) Establishment Name Address ID/FEI Business Operations DMK - Danne Montague King 624242264 label(81537-104) , pack(81537-104) Establishment Name Address ID/FEI Business Operations Creative Essences, Inc. 079120182 manufacture(81537-104)
