Active Ingredients
Octinoxate 7.5%, Zinc Oxide 10.5%
Sun Shield Broad Spectrum Spf 50 Matte
FDA Label NDC 62032-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Omp, Inc. for the product Sun Shield Broad Spectrum Spf 50 Matte (NDC 62032-125). 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, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, 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
Purpose
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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
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
Inactive Ingredients
1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum
Other Information
▪ store at controlled room temperature: 15°C–25°C (59°F–77°F)▪ protect this product from excessive heat and direct sun
Questions Or Comments?
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Principal Display Panel - 85 G Tube Label
OBAGI®
MEDICAL
Sun Shield
MATTE
Broad
Spectrum
SPF 50
Sunscreen
Lotion
Non-Comedogenic
Dermatologist Tested
Net wt. 3 OZ (85 g)
Sun Shield Broad Spectrum Spf 50 Matte Sunscreen Lotion (85g)
* Please review the disclaimer below.
