EAU THERMALE AVENE MINERAL LIGHT HYDRATING SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Titanium Dioxide 4%, Zinc Oxide 6%

Available from:

Pierre Fabre Dermo-Cosmetique USA, 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

EAU THERMALE AVENE MINERAL LIGHT HYDRATING SUNSCREEN SPF 50- TITANIUM
DIOXIDE, ZINC OXIDE LOTION
PIERRE FABRE DERMO-COSMETIQUE USA, 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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_DRUG FACTS_
_ACTIVE INGREDIENTS_
Titanium Dioxide 4%
Zinc Oxide 6%
_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 on damage or broken skin
WHEN USING THIS PRODUCT
Keep out of eyes. Rinse eyes 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_
shake well before use
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
_OTHER INFORMATION_
protect this product from excessive heat and direct sun.
_INACTIVE INGREDIENTS_
Water, Butyloctyl Salicylate, Cetyl Dimethicone, Dimethicone, C12-15
Alkyl Benzoate, Glycerin,
Octyldodecyl Neopentanoate, Trimethylsiloxysilicate, Styrene/Acrylates
Copolymer, Dimethicone
PEG-8 Laurate, Polymethylmethacrylate, Polysorbate 60, Butylene
Glycol, Acrylates/C12-22 Alkyl
Methacrylate Copolymer, Arachidyl Glucoside, Arachidyl Alcohol,
Behenyl Alcohol, Lecithin,
Trisiloxane, Oleic Acid, Benzyl Alcohol, Sorbitol, Xanthan Gum,
Tocopher