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 TINTED FACE 50
_ACTIVE INGREDIENTS_
Titanium Dioxide 4%
Zinc Oxide 4%
_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
DO NOT USE on damaged or broken skin
WHEN USING THIS PRODUCT
WHEN USING THIS PRODUCTkeep out of eyes. Rinse with water to remove.
STOP USE AND ASK A DOCTOR
STOP USE AND ASK A DOCTOR if rash occurs
KEEP OUT OF REACH OF CHILDREN.
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 a
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
Alumina, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetyl
PEG/PPG-10/1
Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium
EDTA,
Disteardimonium Hectorite, Eucalyptus Globulus Leaf Extract, Glycerin,
Hexyl Laurate,
Iron Oxides, Panthenol, PEG-10 Dimethicone, Phenoxyethanol,
Polyglyceryl-4
Isostearate, Polymethylsilsesquioxane, Porphyra Umbilicalis Extract,
Silica, Squalane,
Stearic Acid, Terminalia Ferdinandiana (Kakadu Pl