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Distributed by OMP, Inc.
Nu-derm Sun Shield Spf 50 Sunscreen
FDA Label NDC 62032-124
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 Nu-derm Sun Shield Spf 50 Sunscreen (NDC 62032-124). 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, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, 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 |
|---|---|
| Octinoxate 7.5% | Sunscreen |
| Zinc Oxide 10.5% | Sunscreen |
Uses
- helps prevent sunburn
- higher SPF provides more sunburn protection
- provides high protection against sunburn
Warnings
For external use only.
When Using This Product
- keep out of eyes. rinse with water to remove.
Stop Use And Ask A Doctor If
- rash or irritation develops and lasts.
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 30 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply as needed or after towel drying, swimming, or perspiring.
Other Information
- Store at controlled room temperature:
15°C-30° (59°F-86°F). - Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Inactive Ingredients
Water, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Stearyl Alcohol, Phenyl Trimethicone, PEG-40 Stearate, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Sodium Dihydroxycetyl Phosphate, Citric Acid, Squalane, Ceteareth-20, Polysilicone-11, Dimethicone Crosspolymer-3, Chlorphenesin, Cetearyl Alcohol, Ethoxylated Sorbitan Ester, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Polysorbate 60, Tetrahexyldecyl Ascorbate, Disodium EDTA, Methylisothiazolinone, Hydrogenated Palm Glycerides, Ubiquinone, Tropolone.
Questions?
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Principal Display Panel - 89 Ml Tube Carton
OBAGI®
MEDICAL
Nu-Derm®
Sun Shield
SPF 50
Sunscreen Lotion
High UVA/PA+++
UVB
6
AM
NON-COMEDOGENIC
DERMATOLOGIST TESTED
3 fl. oz. (89 mL)
Principal Display Panel (89 mL Tube Carton)
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