5407 SUNSCREEN octinoxate octisalate oxybenzone titanium dioxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

Innovation Specialties

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 7 g in 100 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

5407 SUNSCREEN- OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
LOTION
INNOVATION SPECIALTIES
_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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5407 SUNSCREEN
_DRUG FACTS_
_ACTIVE INGREDIENT_
Octinoxate 7%
Octisalate 4%
Oxybenzone 3%
Titanium dioxide 4%
_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 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 products is swallowed, get medical
help or contact a Poison Control
Center right away.
_DIRECTIONS_
•apply liberally 15 minutes before sun exposure
•reapply:
•after 40 minutes of swimming or sweating
•immediately after towel drying
•at least every 2 hours
•SUN PROTECTION MEASURE. 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 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
_INACTIVE INGREDIENTS_
Water, C12-15 Alkyl Benzoate, Isopropyl Myristate, Caprylic/Capric
Triglyceride, Cetearyl Alcohol,
CETETH-25, Glyceryl Stearate, Glycerin, Dmdm Hydantoin, Methyl
Paraben, Propylparaben, Fragrance
_OTHER INFORMATION_
•protect this product from excessive heat and direct sun
DIN 02448890
Made in China for Innovation line.
Los Angeles CA 90066
Questions or Comments?
Call:1-855-755-5346
Broad Spectrum SPF30 Sunscreen Lotion
PACKAGING
5407 SUNSCREEN
octinoxate, octisalate, oxybenzone, titanium dioxide lotion
PRODUCT IN