OCTINOXATE, OXYBENZONE, HOMOSALATE

FDA Drug Profile — ALOE KOTE SPF 25

Drug Details

Generic Name
OCTINOXATE, OXYBENZONE, HOMOSALATE
Brand Names
ALOE KOTE SPF 25
Application Number
M020
Sponsor
Aloe Care International, LLC
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
HOMOSALATE, OCTINOXATE, OXYBENZONE

Indications and Usage

Uses helps protect against sunburn higher SPF gives more sunburn protection Uses helps protect against sunburn higher SPF gives more sunburn protection

Warnings

Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product: keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if: rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product: keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if: rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.