AUSTRALIAN GOLD BABY SPF 50 SUNSCREEN- homosalate, octinoxate, octisalate and titanium dioxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

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

AUSTRALIAN GOLD BABY SPF 50 SUNSCREEN- HOMOSALATE, OCTINOXATE,
OCTISALATE AND
TITANIUM DIOXIDE 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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AUSTRALIAN GOLD BABY SPF 50 BROAD SPECTRUM LOTION SUNSCREEN
_ACTIVE INGREDIENTS_
Homosalate 10%
Octinoxate 7.5%
Octisalate 5%
Titanium Dioxide 2.5%
_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
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, C12-15 Alkyl Benzoate,
Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid,
Caprylyl Glycol, Carbomer,
Dimethicone, Disodium EDTA, Fragrance, Glycerin, Helianthus Annuus
(Sunflower) Seed Oil,
Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf
Oil, Olea Europaea (Olive)
Fruit Oil, Polyethylene, Polyhydroxystearic acid, Polysorbate 20,
Propylene Glycol, Sodium
Hydroxide, Sorbitan Oleate, Styrene/Acrylates