SUNBUM SPF 15- avobenzone 2.00% homosalate 5.00% octisalate 2.00% octocrylene 1.85% oxybenzone 3.00% lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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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

INN (International Name):

Avobenzone

Composition:

Avobenzone 2 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Avobenzone 2.00%                        Sunscreen Homosalate 5.00% Octisalate 2.00% Octocrylene 1.85% Oxybenzone 3.00% 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

                                SUNBUM SPF 15- AVOBENZONE 2.00% HOMOSALATE 5.00% OCTISALATE 2.00%
OCTOCRYLENE 1.85%
OXYBENZONE 3.00% LOTION
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 5.00%
Octisalate 2.00%
Octocrylene 1.85%
Oxybenzone 3.00%
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
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
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 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
INACTIVE INGREDIENTS
Behenyl Alcohol
BHT
Butyloctyl Salicylate
Caprylyl Methicone
Dimethicone
Dimethyl Capramide
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Fragrance
Glyceryl Stearate
Hydrated Silica
Methylisothiazolinone
PEG-100 Stearate
Polyaminopropyl Biguanide
Polyester-8
Sodium Polyacrylate
Styrene/Acrylates Copolymer
Tocopheryl Acetate
Trideceth-6
T rimethylsiloxysilicate
VP/Hexadecene Copolymer
Water
Xanthan Gum
SUNBUM SPF 15
avobenzone 2.00% homosalate 5.00% octisalate 2.00% octocrylene 1.85%
oxyb
                                
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