CARIBBEAN BREEZE SPF 50 SUNSCREEN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

Derma Care Research Labs, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen - Helps prevent sunburn - if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Authorization status:

OTC monograph not final

Summary of Product characteristics

CARIBBEAN BREEZE SPF 50 SUNSCREEN- AVOBENZONE 3%, HOMOSALATE 15%,
OCTISALATE 5%, OCTOCRYLENE 10% SPRAY
DERMA CARE RESEARCH LABS, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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CARIBBEAN BREEZE SPF 50
ACTIVE INGREDIENTS
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%
PURPOSE
Sunscreen
USES
Helps prevent sunburn
if used as directed with other sun protection measures (see
Directions) decreases
the risk of skin cancer and early skin aging caused by the sun.
WARNINGS
FOR EXTERNAL USE ONLY. FLAMMABLE: DO NOT USE WHILE SMOKING OR NEAR
HEAT OR
FLAME.
DO NOT USE on damaged or broken skin. WHEN USING THIS PRODUCT keep out
of eyes.
Rinse eyes with water to remove. Contents under pressure. Do not
puncture or
incinerate. Do not store at temperature above 120 degrees F.
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.
DIRECTIONS
Apply liberally 15 minutes before sun exposure. Reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
SUN PROTECTION MEASURES: spending time n the sun increases your risk
of skin
cancer and early skin aging. To decrease risk, regularly use a
sunscreen with broad
spectrum SPF of 15 or higher and other sun protection measure
including:
limit time in the sun, especially from 10 am to 2 pm
wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.
Hold container 4 to 6 inches from the skin to apply. Do not spray
directly into face.
Spray on hands then apply to face. Do no apply in windy conditions.
Use in a well-
ventilated area.
INACTIVE INGREDIENTS
Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Caprylic/Capric
Triglyceride,
Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Tocopherol.
LABEL
CARIBBEAN BREEZE SPF 50 SUNSC