PREMIUM ULTRA UV PURE SUN- octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl sali

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

Purecell Korea Co., Ltd.

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 7 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skn that will be exposed to ultraviolet sunlight.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PREMIUM ULTRA UV PURE SUN- OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE,
DIETHYLAMINO
HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL SALICYLATE,
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL
TRIAZINE STICK
PURECELL KOREA CO., LTD.
_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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Octocrylene, Ethylhexyl Methoxycinnamate, Diethylamino Hydroxybenzoyl
Hexyl Benzoate,
Ethylhexyl Salicylate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine
Water, Butylene Glycol, etc.
Sunscreen
keep out or reach of the children
During the last step of basic skin care, dispense an appropriate
amount and evenly apply to any skn that
will be exposed to ultraviolet sunlight.
DO NOT USE ON DAMAGED OR BROKEN SKIN.
WHEN USING THIS PRODUCT
• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly
with water.
STOP USE IF FOLLOWING SYMPTOMS OCCUR. (CONTINUING IN USAGE MAY
INCREASE SYMPTOMS, ASK
DOCTOR.)
1) If any red spots, swelling, itching, or skin irritation develops.
2) If direct sunlight causes irritation
KEEP OUT OF REACH OF CHILDREN
• Do not swallow. In case of accidental ingestion, get medical help
or contact a Poison Control
Center right away.
STORE AT ROOM TEMPERATURE
• CLOSE LID AFTER USE – possibility of contamination may exists if
displaced contents are replaced back to
container.
for external use only
PREMIUM ULTRA UV PURE SUN
octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl
hexyl benzoate, ethylhexyl salicylate, bis-
ethylhexyloxyphenol methoxyphenyl triazine stick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:716 0 9 -0 0 0 9
ROUTE OF ADMINISTRATION
TOPICAL
Purecell Korea Co., Ltd.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
7 g
in 10 0 g
DIETHYLAMINO HYDRO XYBENZO YL HEXYL BENZO ATE (UNII: ANQ8 70 JD20 )
(DIET