The following Structured Product Label (SPL) was submitted to the FDA by Care One for the product Baby Sunscreen Spf 50 (NDC 41520-364). 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, warnings, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Avobenzone 3.0%..........................Sunscreen
Homosalate 13.0%.........................Sunscreen
Octisalate 5.0%..............................Sunscreen
Octocrylene 7.0%...........................Sunscreen
Oxybenzone 4.0%..........................Sunscreen
For external use only
Do not use on damaged or broken skin
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.
• apply liberally 15 minutes before sun exposure
• 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. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor
* Please review the disclaimer below.
