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Drug Facts
Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806
Obagi
FDA Label NDC 62032-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Obagi Cosmeceuticals Llc for the product Obagi (NDC 62032-150). 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 other, otc - purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
Homosalate 10% Octinoxate 7.5% Titanium dioxide 3.18% | Sunscreen Sunscreen Sunscreen |
Zinc oxide 5% | Sunscreen |
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 doctor if rash occurs▪ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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
Other Information
▪ store at controlled room temperature: 15°C–25°C (59°F–77°F)▪ protect this product from excessive heat and direct sun
Inactive Ingredients
water, butyloctyl salicylate, caprylic/capric triglyceride, caprylyl methicone, polyglyceryl-10 pentastearate, glyceryl stearate, PEG-100 stearate, butylene glycol, pentylene glycol, behenyl alcohol, PEG-40 stearate, dimethicone, physalis angulata extract, algae extract, glycerin, iron oxides, phenoxyethanol, sodium stearoyl lactylate, polyhydroxystearic acid, mannitol, mica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, squalane, alumina, stearic acid, xanthan gum, calcium aluminium borosilicate, diatomaceous earth, Sodium Polyacrylate, disodium EDTA, synthetic fluorphlogopite, polysorbate 60, ethylhexylglycerin, zinc sulfate, Sorbitan Oleate, silica, chlorphenesin, tetrahexyldecyl ascorbate, tin oxide, tocopherol
Questions Or Comments?
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Principal Display Panel - 85 G Tube Carton
OBAGI™
MEDICAL
Sun Shield
TINT
COOL
Broad
Spectrum
SPF 50
Sunscreen
Lotion
Infrared
Defense
Non-comedogenic
Dermatologist tested
Net wt. 3 oz. (85 g)
Principal Display Panel (85 g Tube Carton)
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