BEBAK SUN PROTECTION- octinoxate spray 
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI

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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Bebak Sun Protection Spray

Active Ingredient

Ethylhexyl Methoxycinnamate ....7%

Purpose

Sunscreen

Uses

Protects the skin against the harmful effects of the sun and UV rays

Warnings

For external use only.

In case of an undesired effect regarding the use of this product, consult a doctor. Avoid long-term sunbathin and midday sun even if you had put on sunscreen. Use the product with the sun protectinos factor suitable for your skin.

Contains Benzophenone-3. Do no spray on an open flame or other sources of igniatino. No smoking. Do not expose to sunlight or heat above 50 degrees C. Keep away from sources of ignition.

Avoid eye contact and do not spray directly on the face. In case of eye contact rinse with plenty of water.

Keep out of reach of children.

Directions

Shake before use. Apply on your hands and face by spraying. Dry your skin with a towel after swimming or sweating and repeat.

Inactive Ingredients

Alcohol Denat. Butane, Isobutane, propane, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane, benzophenone-3, polyester-10, propylene glycol dibenzoate, c12-c15 alkyl benzoate, parfum, panthenol, tocopheryl acetate, benzyl alcohol, coumarin, alpha-isomethyl ionone, hydroxycitronellal, butylphenyl methylpropioinal, d-limonene, linalool.

Inactive Ingredients

Alcohol Denat. Butane, Isobutane, propane, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane, benzophenone-3, polyester-10, propylene glycol dibenzoate, c12-c15 alkyl benzoate, parfum, panthenol, tocopheryl acetate, benzyl alcohol, coumarin, alpha-isomethyl ionone, hydroxycitronellal, butylphenyl methylpropioinal, d-limonene, linalool.

PDP

BEBAK SUN PROTECTION 
octinoxate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77462-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10.5 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTANE (UNII: 6LV4FOR43R)  
AVOBENZONE (UNII: G63QQF2NOX)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OCTISALATE (UNII: 4X49Y0596W)  
ALCOHOL (UNII: 3K9958V90M)  
COUMARIN (UNII: A4VZ22K1WT)  
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)  
PANTHENOL (UNII: WV9CM0O67Z)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANE (UNII: T75W9911L6)  
OCTOCRYLENE (UNII: 5A68WGF6WM)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
POLYESTER-10 (UNII: 212N9O2MMZ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77462-008-05150 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/16/2020
Labeler - SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI (366418499)
Establishment
NameAddressID/FEIBusiness Operations
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI366418499manufacture(77462-008)

Revised: 7/2020
Document Id: aa920669-5fec-5696-e053-2a95a90a6d67
Set id: aa920669-5feb-5696-e053-2a95a90a6d67
Version: 1
Effective Time: 20200716
 
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI