Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octinoxate 6% Sunscreen
Octisalate 4% Sunscreen
Octocrylene 2.7% Sunscreen
Skin Balancing Makeup Broad Spectrum Spf 20
FDA Label NDC 68828-194
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jafra Cosmetics for the product Skin Balancing Makeup Broad Spectrum Spf 20 (NDC 68828-194). 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 skin aging caused by the sun
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
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.
Dosage & Administration
Directions
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: Ask a doctor
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
Inactive Ingredient
Inactive ingredients
Water/Aqua, Diisopropyl Sebacate, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI77492/CI 77499, Stearic Acid, PEG-8, Cyclomethicone, Squalane, Mica, Glyceryl Stearate, PEG-100 Stearate, Triethoxycaprylylsilane, Di-PPG-3 Myristyl Ether Adipate, Polysorbate 60, Ethylhexylglycerin, Polymethyl Methacrylate, Proanediol, Caprylyl Glycol, Hexylene Glycol, Methylisothiazolinone, Cetyl Alcohol, Magnesium Aluminum Silicate, Aminomethyl Propanol, Xanthan Gum, Tocopheryl Acetate, Butylene Glycol, Magnesium, Copper, Zinc Glycopeptides, Polydodecanamideaminium Triazadiphenylethenesulfonate, Polyvinylalcohol Crosspolymer, Carica papaya Extract, Glycyrhiza Glabra (Licorice)
Package Label.Principal Display Panel
Skin Balancing Makeup
Broad Spectrum SPF 20
30 ml 1 FL O
Box (Col 423ucskinbalanmkupbsspf20usa)
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