Otc - Active Ingredient
Zinc oxide - 25%
(indicate on manufacturer website for customer to use)
Mama And Hapa S - Bulk Sunscreen Extra Sensitive Cream
FDA Label NDC 83252-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veganic Skn Limited for the product Mama And Hapa S - Bulk Sunscreen Extra Sensitive (NDC 83252-153). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
(indicate on manufacturer website for customer to use)
Indications & Usage
Uses
■ Helps prevent sunburn
■ If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer, and early skin ageing caused by the sun
(indicate on manufacturer website for customer to use)
Warnings
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.
(indicate on manufacturer website for customer to use)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
(indicate on manufacturer website for customer to use)
Dosage & Administration
Directions
■ apply liberally 15 minutes before sun exposure
■ children under 6 months of age: ask a doctor
■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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
■ reapply: ■ after 80 minutes of swimming or sweating
■ immediately after towel drying ■ at least every 2 hours.
(indicate on manufacturer website for customer to use)
Inactive Ingredient
Refer to list provided to customer
(indicate on manufacturer website for customer to use)
Package Label.Principal Display Panel
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