Banana Boat Ultramist Baby Tear Free Continuous Spf 50
FDA Label NDC 17630-2003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accra-pac, Inc. for the product Banana Boat Ultramist Baby Tear Free Continuous Spf 50 (NDC 17630-2003). 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, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Avobenzone 0.03g / 1g

Homosalate 0.15g / 1g

Octinoxate 0.075g / 1g

Octisalate 0.05g / 1g

Octocrylene 0.024g / 1g

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

  • For external use only
  • Do not spray directly into face
  • Flammable do not use near heat, flame, or while smoking

When Using This Product

  • avoid spraying in eyes. If contact occurs, rinse thoroughly with water.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop Use And Ask A Doctor If

irritation or rash develops

Keep Out Of Reach Of Children.

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

Directions

  • shake well before use
  • apply generously and evenly to all areas 15 minutes before sun exposure
  • spray on hands to apply to face
  • use in well-ventilated area
  • reapply at frequent intervals and after swimming or towel drying
  • ask a doctor before use on children under six months of age

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

  • May stain some fabrics.

Inactive Ingredients

Isobutane, Water, Isohexadecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylyl Glycol, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/ Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Glycerin, Tocopheryl Acetate (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Sodium Citrate, Sodium Chloride, Aloe Barbadensis (Aloe Vera) Leaf Juice, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Disodium EDTA

Questions Or Comments?

Call 1-800 SafeSun, Mon-Fri

Distributed by:
SUN PHARMACEUTICALS CORP.
P.O. BOX 7869
DELRAY BEACH, FL 33482

Principal Display Panel

Lotion
UltraMist®
Banana Boat®
Baby
Tear Free®
Continuous Spray Sunscreen
SPF/UVB 50
AvoTriplexTM
UVA Protection
3-Way Protection
Sun-TestedTM, Sun-ProvenTM
No Tearing – Alcohol Free
Very Water Resistant
NET WT. 6 OZ. (170 g)

Principal Display Panelbanana Boat Ultramist Baby Tear Free Continuous Spray Spf 50 (Banana Boat Ultramist Baby Tear Free Continuous Sp 01)

Principal Display Panelbanana Boat Ultramist Baby Tear Free Continuous Spray Spf 50 (Banana Boat Ultramist Baby Tear Free Continuous Sp 01)

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