Otc - Active Ingredient
Zinc Oxide 11%.
Titanium Dioxide 5.6%
Tinted Facial Sunscreen Cream
FDA Label NDC 84066-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Tata Biotechnology Co., Ltd. for the product Tinted Facial Sunscreen (NDC 84066-102). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
helps prevent sunburnifused as directed with other sun protection measures (seeDirections),decreases the risk of skin cancer and early skinaging caused by the sun
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
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.
Dosage & Administration
Directions
apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging
thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher
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.
Other Safety Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Water, lsononyl lsononanoate, Dimethicone, Butylene GlycolGlycerin, Ethylhexyl Palmitate, Phenyl Trimethicone,Hydrogenated Polydecene, Polyglyceryl-3 Diisostearate, CetyPeg/Ppg-10/1 Dimethicone, Silica, DisteardimoniumHectorite, Polyhydroxystearic Acid, Sodium Chloride.Acrylates/Dimethicone Copolymer, Dimethicone/VinylDimethicone Crosspolymer, Sodium Pca, Peg-30Dipolyhydroxystearate, Tribehenin, Magnesium Stearate, Ci77492,Phenoxyethanol, Panthenol, Tocopheryl Acetate, Ci77491, Ethylhexylglycerin, Ci77499, Triethoxycaprylylsilane,PentaerythritylTetra-Di-T-Butyl Hydroxyhydrocinnamate,Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.Saccharide lsomerate, Methylpropanediol, Centella AsiaticaExtract, Polygonum Cuspidatum Root Extract, ScutellariaBaicalensis Root Extract, Camellia Sinensis Leaf Extract,Hibiscus Mutabilis Flower Extract,Nelumbium SpeciosumFlower Extract,1.2-Hexanediol,Rosmarinus Officinalis(Rosemary) Leaf Extract, Chamomilla Recutita (MatricariaFlower Exiract, Hyaluronic Acid, Sodium Levulinate,Silanetriol, Citric Acid, P-Anisic Acid
Otc - Questions
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