SUNBUM SPF 15- avobenzone 2.00% homosalate 6.00% octisalate 2.00% octocrylene 1.85% oxybenzone 2.00% spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

Sun Bum

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Avobenzone 2.00%                        Sunscreen Homosalate 6.00% Octisalate 2.00% Octocrylene 1.85% Oxybenzone 2.00% Uses - helps prevent sunburn - if used as directed with other sun protection messures (see Directions ) decreases the risk of skin cancer and early skin aging caused by sun. Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. Do not use at presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SUNBUM SPF 15- AVOBENZONE 2.00% HOMOSALATE 6.00% OCTISALATE 2.00%
OCTOCRYLENE 1.85%
OXYBENZONE 2.00% SPRAY
SUN BUM
_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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DRUG FACTS
ACTIVE INGREDIENTS PURPOSE
Avobenzone 2.00% Sunscreen
Homosalate 6.00%
Octisalate 2.00%
Octocrylene 1.85%
Oxybenzone 2.00%
US ES
- helps prevent sunburn
- if used as directed with other sun protection messures (SEE
DIRECTIONS) decreases the risk of skin
cancer and early skin aging caused by sun.
WARNINGS
FOR EXTERNAL USE ONLY
FLAMMABLE: Contents under pressure. Do not puncture or incinerate. Do
not store at temperature above
120F. Do not use at presence of a flame or spark. Keep away from
sources of ignition – No smoking.
INTENTIONAL MISUSE by deliberately concentrating and inhaling the
contents can be harmful or fatal.
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 product is swallowed, get medical
help or contact a Poison Control
Center right away.
DIRECTIONS
• Hold container 4-6 inches from skin to apply.
• Spray liberally and spread evenly by hands 15 minutes before sun
exposure
• Do not spray directly into face. Spray on hands then apply to
face.
• Do not apply in windy conditions. Use in well-ventilated area.
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
• SUN PROTECTION MEASURES. Spending time in the sun
increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a
broad spectrum SPF of 15 or higher and other sun
protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor