AUSTALIAN GOLD BROAD SPECTRUM SPF 15 SUNSCREEN- octisalate, avobenzone, octocrylene spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

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 - 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

AUSTALIAN GOLD BROAD SPECTRUM SPF 15 SUNSCREEN- OCTISALATE,
AVOBENZONE,
OCTOCRYLENE SPRAY
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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AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 15 SUN SCREEN
INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl
Methacrylate Copolymer,
Aloe Barbadensis Leaf Juice, Butylphthalimide, Caramel, Dimethicone,
Ethylhexylglycerin, Fragrance,
Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl
Methylcellulose,
Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea
Europaea (Olive) Fruit Oil,
Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide,
Sorbitan Oleate, Terminalia
Ferdinandiana (Kakadu Plum) Fruit Extract, Tetrasodium Glutamate
Diacetate, Tocopheryl Acetate,
Trimethylsiloxysilicate, Water
_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.
Keep away from face to avoid
breathing it.
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.
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.
_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
_ACTIVE INGREDIENTS_
Avobenzone 2.0%
Octocrylene 2%
Octisalate 5.0%
_DIRECTIONS_
apply liberally 15 minutes before sun exposure and rub into skin
hold container 4 to 6 inches from the skin to apply
do not spray directly on to