FDA Label for Sun Defense Spf 15
View Indications, Usage & Precautions
Sun Defense Spf 15 Product Label
The following document was submitted to the FDA by the labeler of this product Kamins Dermatologics Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients:
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Oxybenzone 6%
Otc - Purpose
Purpose: Sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
A broad spectrum UVA/UVB sunscreen to help protect the skin from sunburn. Sun Defense Spray SPF 15 is enriched with moisturizing açai oil, pomegranate extract and Bio-MapleTM compound to help skin remain hydrated.
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.
Flammable: Keep away from open flame or source of heat. Do not use while smoking. Avoid long term storage above 40 °C (104°F)
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.Dosage & Administration
Directions
■ Apply 15-30 minutes before sun exposure.
■ Hold bottle 8-10 inches from the skin and press pump to spray a fine even
mist.
■ Spray liberally and evenly over all exposed areas to ensure complete coverage.
■ Do not spray directly onto face; spray into hands, then immediately apply to face.
■ Rub into skin on all exposed areas.
■ Reapply every two hours or as needed, after swimming, washing, towel drying, or perspiring heavily.
Inactive Ingredient
Inactive ingredients: alcohol denat., ethyl macadamiate, tocopherol, malic acid, diethylhexyl 2,6-naphthalate, PPG-5-ceteth-20, acrylates/octylacrylamide copolymer, ethylene brassylate, lauryl PCA, tocopheryl acetate, acer saccharum (maple isolate), punica granatum (pomegranate) extract, propylene glycol, water, euterpe oleracea (acai) oil, retinyl palmitate, magnesium ascorbyl phosphate.
Package Label.Principal Display Panel
B. KAMINS
SUN DEFENSE SPRAY SPF15
150mL / 5 fl.oz
DIN 02312484
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