SUNOF SUNSCREEN FACE CREAM SPF 50- octinoxate, octisalate, avobenzone cream

SUNOF Sunscreen Face Cream SPF 50 by

Drug Labeling and Warnings

SUNOF Sunscreen Face Cream 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

Aqua , Ethylhexyl Triazone, Ethylhexyl Stearate ,Styrene/Acrylates Copolymer , Glyceryl Stearate , PEG-100 Stearate , Cetearyl Alcohol , Acrylates/ Copolymer , Phenoxyethanol ,Parfum , Ethylhexylglycerin ,Panthenol , Sodium Hydroxide.

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.

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

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.

Keep out of reach of children

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

Direction

Apply generously 15 minutes before sun exposure. 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

Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNOF SUNSCREEN FACE CREAM SPF 50 
octinoxate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77418-005
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AQUA (UNII: 059QF0KO0R)
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW) (UNII: 3K8D4YRM4R)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PANTHENOL (UNII: WV9CM0O67Z)
PARFUMIDINE (UNII: A2Q2LHC6MA)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77418-005-01	50 mL in 1 TUBE; 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(77418-005)