Otc - Active Ingredient
Active ingredients:
Ensulizole 3%
Homosalate 10%
Octinoxate 7.5%
Octocrylene 7%
Zinc oxide 8%
Sun Defense Uvscreen Spf 48
FDA Label NDC 63550-852
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kamins Dermatologics Inc. for the product Sun Defense Uvscreen Spf 48 (NDC 63550-852). 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
Purpose: Sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
A hydrating, broad spectrum UVA/UVB sunscreen, which provides protection against sunburn. Combines our moisturizing Bio-MapleTM compound with a mixture of sunscreens that protect skin by scattering, reflecting and absorbing harmful sun rays. Fragrance, color and oil-free, ideal for those with sensitive skin.
Uses
■ Helps prevent sunburn.
■ Higher SPF gives more sunburn protection.
■ Provides high protection against sunburn.
Warnings
Warnings
For external use only.
Avoid contact with eyes when using this product. If contact occurs, rinse abundantly with water to remove.
Discontinue
use in case of excessive skin irritation or if condition does not
improve. If irritation persists, consult a health care practitioner.
If swallowed, seek medical assistance or contact a Poison Control
Center immediately.
Other information
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.Store at room temperature 15-30°C (59-86°F).
Dosage & Administration
Directions
■ Apply liberally and evenly to face and exposed areas 15-30 minutes before sun exposure.
■ Apply liberally and evenly to face and exposed areas 15-30 minutes before sun exposure.
■ Reapply every two hours or as needed.
■ Reapply
after swimming, towel drying, washing or perspiring heavily.
■ Consult a doctor before using on children under six months of age.
Inactive Ingredient
Inactive ingredients: water, cyclopentasiloxane, dimethiconol, acer
saccharum (maple isolate), glycerin,
cyclohexasiloxane, cetearyl alcohol, steareth-100, polyacrylamide,
C13-14 isoparaffin, laureth-7, steareth-2, dimethicone, VP/eicosene copolymer, lactic acid, sodium
hydroxide, dimethoxydiphenylsilane/triethoxycaprylylsilane crosspolymer, tocopheryl acetate, xanthan
gum, phenoxyethanol, chlorphenesin.
Package Label.Principal Display Panel
SUN DEFENSE UVscreen SPF 48
120 mL / 4 fl. oz
DIN 02280329
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120 mL / 4 fl. oz
DIN 02280329
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Sun Defense Uv Screen Spf Front Panel Image (Sundefense Uvscreen)
* Please review the disclaimer below.
