Otc - Active Ingredient
Active Ingredients:
Zinc Oxide 22.0%
Purpose: Sunscreen
Kids Mineral Sunscreen Stick Spf 50 Stick
FDA Label NDC 83369-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smalls Brand Llc Dba Roe Wellness for the product Kids Mineral Sunscreen Stick Spf 50 (NDC 83369-004). 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
Warning:
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.
Dosage & Administration
Directions:
- Apply liberally 15 minutes before sun or water exposure
- ReapplyImmediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
Inactive Ingredient
Caprylic/capric Triglyceride, Ethylhexyl Olivate, Bis-Octyldodecylhexyl Dimer Dilinoleate Propanediol Copolymer, Coco-Caprylate/Caprate, Cocoglycerides, Candelilla (Euphorbia Cerifera) Wax, Ozokerite , Rhus Verniciflua Peel Wax, Jojoba Esters, Butylocyl Salicylate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Olivoyl Hydrolyzed Oat Protein, Squalane, Cetearyl Alcohol, Glyceryl Stearate, Tocopherol, Stearalkonium Hectorite, Olea Europaea (Olive) Oil Unsaponifiables, Stearyl Glycyrrhetinate, Glyceryl Oleate, Water, Propylene Carbonate, Caprylyl Glycol, Bisabolol
Package Label.Principal Display Panel
Kids Mineral Sunscreen Stick
0.7 fl oz 20 g
* Please review the disclaimer below.
