Label: NEW KID ON THE BLOCK- zinc oxide lotion
- NDC Code(s): 84568-552-12
- Packager: Dimples Bath Co. LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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Directions
Directions • Apply liberally 15 minutes before sun exposure • Reapply after 80 minutes of swimming or sweating • Immediately after towel drying at least every 2 hours • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protecting measures including • Limit time in the sun, especially from 1Oam - 2pm Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months Ask a doctor
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INACTIVE INGREDIENT
Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, , Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) OiI, Diheptyl Succinate, Ethylhexlglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NEW KID ON THE BLOCK
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84568-552 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 g in 100 g Inactive Ingredients Ingredient Name Strength POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.1 g in 100 g BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 5 g in 100 g SODIUM HYALURONATE (UNII: YSE9PPT4TH) 0.2 g in 100 g SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) 1.3 g in 100 g METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 3 g in 100 g BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y) 2.1 g in 100 g TOCOPHEROL (UNII: R0ZB2556P8) 0.1425 g in 100 g BETA-SITOSTEROL (UNII: S347WMO6M4) 0.075 g in 100 g CETEARYL ALCOHOL (UNII: 2DMT128M1S) 1.3 g in 100 g CITRIC ACID (UNII: 2968PHW8QP) 0.2 g in 100 g ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 g in 100 g COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L) 8 g in 100 g MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 1.056 g in 100 g SQUALENE (UNII: 7QWM220FJH) 0.0375 g in 100 g THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR) 0.8 g in 100 g SODIUM GLUCONATE (UNII: R6Q3791S76) 0.2 g in 100 g BISABOLOL (UNII: 24WE03BX2T) 0.3 g in 100 g HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI) 0.495 g in 100 g COCO-GLUCOSIDE (UNII: ICS790225B) 0.7 g in 100 g BEHENYL ALCOHOL (UNII: 9G1OE216XY) 0.54 g in 100 g CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) 1.8 g in 100 g WATER (UNII: 059QF0KO0R) 46.3 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 g in 100 g DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) 3.2 g in 100 g CETYL ALCOHOL (UNII: 936JST6JCN) 0.75 g in 100 g CELLULOSE GUM (UNII: K679OBS311) 0.144 g in 100 g ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) 0.27 g in 100 g ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) 0.99 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84568-552-12 106.8 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/01/2024 Labeler - Dimples Bath Co. LLC (119296438)
