OKEEFFES LIP REPAIR- avobenzone, dimethicone, octinoxate, octocrylene ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

The Gorilla Glue Company/O'Keeffe's Company

INN (International Name):

AVOBENZONE

Composition:

AVOBENZONE 2.5 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes Sunscreen Lip Protectant Sunscreen Sunscreen Uses - temporarily protects and helps relieve chapped or cracked lips - 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 Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

OKEEFFES LIP REPAIR- AVOBENZONE, DIMETHICONE, OCTINOXATE,
OCTOCRYLENE OINTMENT
THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY
_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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O'KEEFFE'S LIP REPAIR SPF 35 TUBE
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Avobenzone 2.5%
Dimethicone 17.5%
Octinoxate 6%
Octocrylene 2%
_PURPOSES_
Sunscreen
Lip Protectant
Sunscreen
Sunscreen
_USES_
temporarily protects and helps relieve chapped or cracked lips
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 ASK A DOCTOR IF rash occurs
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
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 value 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-sleeved 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_ Beeswax, Petrolatum, Phenyl Trimethicone,
Hydrogenated Poly
(C6-14 Olefin), Butyrospermum Parkii (Shea) Butter,
Trimethylpentanediol/Adipic
Acid/Glycerin Crosspolymer, Hydrogenated Polyisobutane, Prunus
Amygdalus Dulcis
(Sweet Almond) Oil, Polysilicone-11, Flavor, Hydrogenated Vegetable
Oil,
Ethylene/Propylene/Styrene Copolyme