Otc - Active Ingredient
Active ingredient Purpose
Zinc Oxide 15% .......................................................... Sunscreen
Sunscreen Spf 30
FDA Label NDC 72381-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hamilton Therapeutics for the product Sunscreen Spf 30 (NDC 72381-102). 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, otc - keep out of reach of children, indications & usage, warnings, 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
Uses
• Helps prevent sunburn
• If used as directed with other sun protection measures (
see Directions), decreases the risk of
skin cancer and early aging caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
• Stop use and ask a doctor if rash occurs.
Warnings
Warnings
• For external use only
• When using this product keep out of eyes.
• Rinse with water to remove.
• Do not use on damaged or broken skin.
Dosage & Administration
Directions
• For full protection, apply liberally 15 minutes before sun exposure.
• Reapply: • After 40 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours.
• For children under 6 months: Ask a doctor. • Sun Protection Measures: To decrease risk of exposure, regularly use a Broad Spectrum Sunscreen with an SPF of 15 or higher.
• Limit time in the sun, especially from 10AM-2PM.
• Wear long-sleeved shirts, pants, hats and sunglasses.
Inactive Ingredient
Inactive ingredients Water, Caprylyl Caprylate/Caprate, Coconut Alkanes, Potassium Cetyl Phosphate, Cetearyl Alcohol, Glycerin, Bisabolol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Coco-Caprylate/Caprate, Glyceryl Stearate, Xanthan Gum, Polyhydroxystearic Acid, Glyceryl Distearate, Stearic Acid, Potassium Stearate, Octyldodecanol, Ethylhexyl Neopentanoate, Dimethicone, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylhydroxamic Acid.
Package Label.Principal Display Panel
SPF 30 Sunscreen
3.3FL OZ / 98mL
Tube (Sunscreen 3 3oz Tube)
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