SUNOF SUNSCREEN SPF 50- avobenzone, octisalate, octinoxate aerosol

SUNOF Sunscreen SPF 50 by

Drug Labeling and Warnings

SUNOF Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredients

Alcohol Denat. , Isopropyl Myristate , Butane , Isobutane , Propane , Ethylhexyl Triazone

Acrylates/Octylacrylamide Copolymer , Parfum , Tocopheryl Acetate , Panthenol

WARNINGS

For external use only.

Do not use on damaged or broken skin.

When using this Product Keep away from face to avoid breathing it

Keep out of eyes.Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

Flammable

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 F . Do not use in the presence of a flame or spark . Keep away from sources of ignition-No smoking . Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Keep out of reach of children.

If Product is swallowed , get medical help or contact a Poison Control Center right away.

Directions

Shake well . Hold container 4 or 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Do not spray directly into face. Spray on hands and then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.Reapply : after 80 minutes of swimming or sweating.Immediately after towel drying. 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 this risk , regularly use a sunscreen with a board 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.

Uses

Helps prevent sunburn

If used as directed with other sun proctection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

PURPOSE

Helps prevent sunburn

SUN SCREEN SPRAY

INGREDIENTS AND APPEARANCE

SUNOF SUNSCREEN SPF 50 
avobenzone, octisalate, octinoxate aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77418-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
PARFUMIDINE (UNII: A2Q2LHC6MA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOBUTANE (UNII: BXR49TP611)
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PANTHENOL (UNII: WV9CM0O67Z)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
1,3-BIS(DIPHENYLPHOSPHINO)PROPANE (UNII: 44R56E2C68)
1,3-BUTANEDITHIOL (UNII: 85VJA9KBCH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77418-003-01	200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/05/2025

Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)

Registrant - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)

Establishment
Name	Address	ID/FEI	Business Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI		566218248	manufacture(77418-003)