banana boat kids mineral vanishing blue foam spf 50 berry blast

banana boat kids mineral vanishing blue foam spf 50 berry blast
SPL v2
SPL
SPL Set ID bf4cc838-7884-b91e-e053-2a95a90a50fe
Route
topical
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (49 mg) zinc cation (71 mg)
Inactive Ingredients
peg-8 dimethicone vinylpyrrolidone/eicosene copolymer water isobutane medium-chain triglycerides isohexadecane butyloctyl salicylate sodium chloride ethylhexyl methoxycrylene dimethicone polyhydroxystearic acid (2300 mw) phenoxyethanol caprylyl glycol polyethylene glycol 400 aluminum oxide glycerin sodium citrate .alpha.-tocopherol acetate d&c green no. 6 tricaprin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-04-01

Purpose

Sunscreen

Description

Titanium Dioxide 4.9%, Zinc Oxide 7.1%


Medication Information

Warnings

For external use only - Do not consume.

May stain or damage some fabrics or surfaces.

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Directions
  • Shake well 
  • Dispense in upright position for optimal results
  • Hold container 4 to 6 inches from the skin to apply 
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
  • Do not spray directly into 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 
  • 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses  Sun Protection Measures.
  • Children under 6 months: Ask a doctor.
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water, Isobutane, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Fragrance, Sodium Citrate, Tocopheryl Acetate, Green 6.

Description

Titanium Dioxide 4.9%, Zinc Oxide 7.1%

Do Not Use

on damaged or broken skin.

Drug Facts

Package Labeling:

Active Ingredients

Titanium Dioxide 4.9%, Zinc Oxide 7.1%

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product
  • 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.


Structured Label Content

Warnings

For external use only - Do not consume.

May stain or damage some fabrics or surfaces.

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Directions
  • Shake well 
  • Dispense in upright position for optimal results
  • Hold container 4 to 6 inches from the skin to apply 
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
  • Do not spray directly into 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 
  • 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses  Sun Protection Measures.
  • Children under 6 months: Ask a doctor.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water, Isobutane, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Fragrance, Sodium Citrate, Tocopheryl Acetate, Green 6.

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Package Labeling:

Active Ingredients

Titanium Dioxide 4.9%, Zinc Oxide 7.1%

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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