Label: MEIJER BABY TEAR FREE SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 41250-705-57
- Packager: Meijer Distributing Inc.
- Category: HUMAN OTC DRUG LABEL
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 June 1, 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: Ask a doctor
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Inactive ingredients
Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.
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INGREDIENTS AND APPEARANCE
MEIJER BABY TEAR FREE SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-705 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.2 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOHEXADECANE (UNII: 918X1OUF1E) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-705-57 295 g in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2016 Labeler - Meijer Distributing Inc. (006959555)