Label: MEIJER ZINC SPF 50- octocrylene, zinc oxide lotion
- NDC Code(s): 41250-796-83
- Packager: Meijer Distribution, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 March 10, 2016
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- Active Ingredients
- Purpose
- Uses
- Warnings
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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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. to 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor
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Inactive ingredients
Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane, Sodium Chloride, Hydrogenated Castor Oil, Silica, Triethoxycaprylylsilane, Dimethicone, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, henoxyethanol, Methylparaben, Propylparaben.
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INGREDIENTS AND APPEARANCE
MEIJER ZINC SPF 50
octocrylene, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-796 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) YELLOW WAX (UNII: 2ZA36H0S2V) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-796-83 118 g in 1 TUBE; Type 0: Not a Combination Product 04/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/10/2016 Labeler - Meijer Distribution, Inc. (006959555)
