BEBAK SUN PROTECTION- octinoxate spray

Bebak Sun Protection by

Drug Labeling and Warnings

Bebak Sun Protection by is a Otc medication manufactured, distributed, or labeled by SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WHEN USING

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEBAK SUN PROTECTION 
octinoxate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77462-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10.5 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77462-008-05	150 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/16/2020

Labeler - SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI (366418499)

Establishment
Name	Address	ID/FEI	Business Operations
SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI		366418499	manufacture(77462-008)