Label: MEIJER BABY TEAR FREE SPF 50 CS- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 41250-921-55
- 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 11, 2016
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- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF. Do not use in the presence of a flame or spark. Keep away from sources of ignition-No smoking.
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Directions
- hold container 4-6 inches from the skin to apply
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- Do not spray directly on face. Spray on hands then apply to face.
- do not apply in windy conditions
- use in well-ventilated area
- 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
Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.
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- Principle Display Label
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INGREDIENTS AND APPEARANCE
MEIJER BABY TEAR FREE SPF 50 CS
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-921 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) 2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) DIBUTYL ADIPATE (UNII: F4K100DXP3) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) PEG-8 DIMETHICONE (UNII: GIA7T764OD) ALOE VERA LEAF (UNII: ZY81Z83H0X) OCTYLDODECANOL (UNII: 461N1O614Y) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-921-55 170 g in 1 BOTTLE, SPRAY; 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 03/11/2016 Labeler - Meijer Distribution, Inc. (006959555)