SUNTONE BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

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:

Prime Enterprises Inc.

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 final

Summary of Product characteristics

SUNTONE BROAD SPECTRUM SPF 50 SUNSCREEN- AVOBENZONE, HOMOSALATE,
OCTISALATE,
OCTOCRYLENE, AND OXYBENZONE LOTION
PRIME ENTERPRISES INC.
_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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SUNTONE BROAD SPECTRUM SPF 50 SUNSCREEN
_ACTIVE INGREDIENTS_
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 2.75%
Oxybenzone 3%
_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.
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
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf
Juice, Butylphthalimide, C12-
15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum),
Hydroxypropyl Methylcellulose,
Isopropylphthalimide, Methylisothiazolinone, Methylparaben,
Polyethylene, Polysorbate 20, Propylene
Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed
Butter, Tocopheryl Acetate,
Triethanolamine, Water (Aqua)
_OTHER INFORMATION_
protect this product from excesive heat and direct sun
_QUESTIONS