ENVIRON SUNCARE BROAD SPECTRUM SPF 30- titanium dioxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

Dermacare USA, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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 not final

Summary of Product characteristics

ENVIRON SUNCARE BROAD SPECTRUM SPF 30- TITANIUM DIOXIDE CREAM
DERMACARE 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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ENVIRON SUNCARE BROAD SPECTRUM SPF-30
DRUG FACTS:
_ACTIVE INGREDIENTS_
Titanium Dioxide 8%
_PURPOSE_
Sunscreen
US ES :
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 damaged or broken skin.
WHEN USING THIS PRODUCT
keep out of eyes. Rinse with water to remove.
STOP USE AND CONSULT A PHYSICIAN
if irritation or rash develops.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical attention or contact a poison control center
immediately.
DIRECTIONS :
• Apply liberally 15 minutes before sun exposure.
• Reapply
- at least every 2 hours.
- immediately after swimming, sweating or towel drying.
• 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 rating of 15 or
higher, along with other sun protection measures including:
- Limit time in the sun, especially between 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Children under 6 months, consult a physician.
INACTIVE INGREDIENTS:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),
Bis-Vinyl
Dimethicone/Dimethicone Copolymer, Butyloctyl Salicylate, C12-15 Alkyl
Benzoate, Camellia Sinensis
(Green) Tea Extract, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil,
Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Ethylhexyl
Palmitate, Glycerin, Glycine
Soja (Soybean) Oil, Hyaluronic Acid, C13-14 Isoparaffn, Laureth-7,
Lecithin, Leontopodium Alpinum
(Edelweiss) Extract, Phenoxyethanol, Polyacrylamide,
Polyhydroxystearic Acid, Polysorba