Otc - Active Ingredient
Active ingredients:
Avobenzone 2.5%
Octinoxate 7.5%
Oxybenzone 6%
Titanium dioxide 2%
Sun Defense Spf 30
FDA Label NDC 63550-851
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 Spf 30 (NDC 63550-851). 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
This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides important protection against the sun’s harmful rays. Recommended for use on face and body, for everyday wear and outdoor activities. This cosmetically elegant formula is non-greasy, leaves a matte finish, and can be reapplied over makeup.
• fragrance-free • oil-free
• for face and body
Uses
■ Helps prevent sunburn.
■ Higher SPF gives more sunburn protection.
■ Provides high protection against sunburn.
Warnings
Warnings
For external use only.
When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
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.
■ Children under 6 months of age: ask a doctor.
Inactive Ingredient
Inactive ingredients: water, octyldodecyl neopentanoate, propylene glycol, acer saccharum, tocopheryl acetate, cetyl alcohol, stearic acid, DEA-cetyl phosphate, panthenol, dimethicone, xanthan gum, carbomer, sodium hydroxide, phenoxyethanol, chlorphenesin, BHT, iron oxides (CI 77491).
Package Label.Principal Display Panel
SUN DEFENSE SPF 30
120 mL / 4 fl. oz
DIN 02241810
image/jpg
120 mL / 4 fl. oz
DIN 02241810
image/jpg
Sun Defense Spf Front Panel Image (Sundefense Spf Thirty)
* Please review the disclaimer below.
