Active Ingredients
Zinc Oxide 17%
Avatara Kom Bu Cha The Simple Shield Balancing Oil-free Moisturizer Spf 30 Lotion
FDA Label NDC 83126-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avatara Personal Care Llc for the product Avatara Kom Bu Cha The Simple Shield Balancing Oil-free Moisturizer Spf 30 (NDC 83126-101). 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, uses, warnings, directions, inactive ingredients, other information, questions?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
• helps prevent sunburn • if used as directed with other
sun protection measures (see Directions), decreases the
risk of skin cancer and early skin aging caused by the sun
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 docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
• apply generously 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• 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
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
• children under 6 months of age: Ask a doctor
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Glycerin, Butyloctyl Salicylate, Glyceryl Stearate, Polyhydrostearic Acid, PEG-100 Stearate, Butylene Glycol, Polyglyceryl-2 Stearate, Potassium Cetyl Phosphate, Cetyl Alcohol, Cetearyl Alcohol, Xanthan Gum, Pongamol, Saccharomyces/Xylinum/Black Tea Ferment, Ethylhexylglycerin, Xylitylglucoside, Anhydroxylitol, Tocopherol, Xylitol, Trisodium Ethylenediamine Disuccinate, Salicylic Acid, Ceramide NG, Chichorium Intybus (Chicory) Root Extract, Pentylene Glycol, Sodium Hyaluronate, Polysorbate 20
Other Information
• protect the product in this container from excessive
heat and direct sun
Questions?
Call 1-888-883-5507
Principal Display Panel
83126-100-01 (83126 100 01)
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