Kids Sunscreen Spf 50
FDA Label NDC 47124-338

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wegman for the product Kids Sunscreen Spf 50 (NDC 47124-338). 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, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients                         Purpose

Homosalate 6.0%....................................................Sunscreen
Octinoxate 7.5%......................................................Sunscreen
Octisalate 5.0%.......................................................Sunscreen
Octocrylene 10.0%..................................................Sunscreen
Zinc Oxide 8.0%......................................................Sunscreen

Warnings

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.

Directions

• 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

Inactive Ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, C12-15 Alkyl
Benzoate, Caprylyl Glycol, Ceresin, Chamomilla Recutita
(Matricaria) Flower Extract, Copernicia Cerifera (Carnauba)
Wax, Dimethicone, Ethyl Macadamiate, Ethylhexyl Palmitate,
Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated
Polyisobutene, Hydrogenated Vegetable Oil, Lavandula
Angustifolia (Lavender) Extract, Octyldodecanol, Polyethylene,
Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sorbitan
Sesquioleate, Tocopheryl Acetate, Triethoxycaprylylsilane

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