RECAPTURE 360 DAY PLUS IR DEFENSE- avobenzone, octocrylene, and octinoxate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

Atlantic Coast Media Group, LLC.

INN (International Name):

AVOBENZONE

Composition:

AVOBENZONE 30 mg in 1 mL

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 final

Summary of Product characteristics

RECAPTURE 360 DAY PLUS IR DEFENSE- AVOBENZONE, OCTOCRYLENE, AND
OCTINOXATE CREAM
ATLANTIC COAST MEDIA GROUP, LLC.
_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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RECAPTURE 360 DAY + IR DEFENSE
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Avobenzone 3.0%
Sunscreen
Octinoxate 7.5%
Sunscreen
Octocrylene 4.2%
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.
STOP USE AND ASK A DOCTOR IF rash occurs.
WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
SUN PROTECTION MEASURES. Spending time in the sun increases your risk
of skin cancer and early
skin aging. To decrease 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
OTHER INFORMATION
Protect the product in this container from excessive heat and direct
sunlight
You may report a serious adverse reaction from using this product to
Report Reaction, LLC.
PO Box 22, Plainsboro, NJ 08536-0222
INACTIVE INGREDIENTS
Water, Isododecane, Cyclopentasiloxane, Cetyl Alcohol, Butylene
Glycol, Glycerin, Glyceryl Stearate,
PEG-100 Stearate, Sodium Potassium Aluminum Silicate, Ethylhexyl
Methoxycrylene,
Xylitylglucoside, Diethylhexyl Syringylidenemalonate, Phormidium
Persicinum Extract, Laminaria
Digitata Extract, Simmondsia Chinensis (J