RAYDIANT BY AUSTRALIAN GOLD VITAMIN D BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lot

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

RAYDIANT BY AUSTRALIAN GOLD VITAMIN D BROAD SPECTRUM SPF 50-
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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ACTIVE INGREDIENTS
Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %,
Oxybenzone 3 %
PURPOS E
Sunscreen
US ES
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
INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf
Juice, Butylphthalimide, C12-
15 Alkyl Benzoate, Carbomer, Cholecalciferol, Disodium EDTA, Fragrance
(Parfum), Hydroxyprophyl
Methylcellulose, Isopropylphtalimide, Methylisothiazolinone,
Phenoxyethanol, Polyethylene,
Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Theobroma Cacao
(Cocoa) Seed
Buter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)
OTHER INFORMATION
protect this product from excesive heat and direct sun
QUESTION