Meijer Baby Tear Free Spf 50 Cs Spray
FDA Label NDC 41250-921

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution, Inc. for the product Meijer Baby Tear Free Spf 50 Cs (NDC 41250-921). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Label (92155)

Label (92155)

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