Sunzone Baby Sunscreen Spf-60
FDA Label NDC 50021-241

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Empack Spraytech Inc. for the product Sunzone Baby Sunscreen Spf-60 (NDC 50021-241). 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, otc - when using, otc - ask doctor, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone......3%

Octinoxate........4%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Otc - When Using

When using the product do not get into eyes. If contact occurs, rinse thoroughly with water

Otc - Ask Doctor

Stop use and ask a doctor if irritaion occurs

Keep Out Of Reach Of Children

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

Directions

  • Apply liberally and spread evenly 15 minutes before sun exposure
  • Reapply after 80 minutes of swimmin or sweating
  • immediately after swimming, towel drying
  • At least every 2 hours

    • SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin damage. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including;

    • Limit time in the sun, especially from 10 a.m-2p.m
    • Wear long-sleeve shirts, pants, hats and sunglasses

      • Children under 6 months: ASK A DOCTOR

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzoate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (safflower) Oleosomes, dl-alpha Tocopheryl acetate, Ethylhexylglycerin, fragrance, glycerin, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Phenyl Trimethicone, Water

Information

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Question Or Comments

Call toll free 1-866-923-2665

Empack Spraytech Inc.

98 walker Drive, Brampton, Ontario

L6T 4H6

www.sunzone.ca

Made in Canada

Please Recycle

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