AUSTALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

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 50 SUNSCREEN- TITANIUM DIOXIDE, ZINC
OXIDE 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 BOTANICAL SUNSCREEN BROAD SPECTRUM SPF 50
INACTIVE INGREDIENTS
Cyclopentasiloxane, Water, Glycerin, Silica, Cetyl PEG/PPG-10/1
Dimethicone, Disteardimonium
Hectorite, Polymethylsilsesquioxane, PEG-10 Dimethicone, Hexyl
Laurate, Polyglyceryl-4 Isostearate,
Dimethicone Crosspolymer, Fragrance, Stearic Acid, Phenoxyethanol,
Alumina, Caprylyl Glycol,
Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Panthenol,
Squalane, Disodium EDTA,
Eucalyptus Globulus (Eucalyptus) Leaf Extract, Porphyra Umbilicalis
Extract, Terminalia Ferdinandiana
(Kakadu Plum) Fruit Extract
_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_
Titanium Oxide 4%
Zinc Oxide 4%
_DIRECTIONS_
apply liberally 15 minutes before sun exposure and rub into skin
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
SUN PROTECTION MEASURES Spending time ine the sun increases your risk
of skin cancer and ear