MEIJER BABY TEAR FREE SPF 50 CS- avobenzone, homosalate, octisalate, octocrylene spray

meijer Baby Tear Free SPF 50 CS by

Drug Labeling and Warnings

meijer Baby Tear Free SPF 50 CS by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Purpose

Sunscreen

Uses

    helps prevent sunburn

    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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.

Do not use

on damaged or broken skin

When using this product

• Keep away from face to avoid breathing it
• Keep out of eyes.  Rinse with water to remove.
  

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

• Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.   

• May stain some fabrics

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

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.

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-697-9868  Mon-Fri

Principle Display Label

NDC:  41250-921-55

meijer

tear free

baby Sunscreen

continuous spray

pediatrician tested

UVA/UVB protection

50+

Broad Spectrum SPF 50+

Water Resistant

(80 minutes)

Net Wt 6 OZ. (170 g)

INGREDIENTS AND APPEARANCE

MEIJER BABY TEAR FREE SPF 50 CS 
avobenzone, homosalate, octisalate, octocrylene spray

Product 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)