BEBAK BABY SUN- oxybenzone lotion

Bebak Baby Sun by

Drug Labeling and Warnings

Bebak Baby Sun 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

Oxybenzone.......8.5%

Purpose

Sunscreen

Uses

Provides a high degree of protection against the harmful UVA and UVB rays of the sun

Warnings

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

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

Apply a sufficient quantity of the product evenly on clean and dry skin before going out in the sun. Repeat application frequently.

Inactive Ingredients

Aqua, Benzophenone-3, Octocrylene, Glyceryl Stearate, Homosalate, Butyl Methoxydibenzoylmethane, PEG-100 Stearate, Cetearyl Alcohol, Ceteareth-20, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Ethylhexyl Palmitate, Trimethylsiloxysilicate, Phenylbenzimidazole Sulfonic Acid, Phenoxyethanol, Triethanolamine, Inulin, Chlorphenesin, Xanthan Gum, Glycerin, Fructose, Hydroxyethylcellulose, Helianthus Annuus Seed Oil, Sodium Acetate, Cellulose, Daucus Carota Sativa Extract, Beta-Carotene, Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEBAK BABY SUN 
oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77462-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	17 g  in 200 g

Inactive Ingredients
Ingredient Name	Strength
FRUCTOSE (UNII: 6YSS42VSEV)
TROLAMINE (UNII: 9O3K93S3TK)
AVOBENZONE (UNII: G63QQF2NOX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ACETATE (UNII: 4550K0SC9B)
CARROT (UNII: L56Z1JK48B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HOMOSALATE (UNII: V06SV4M95S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
OCTOCRYLENE (UNII: 5A68WGF6WM)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORPHENESIN (UNII: I670DAL4SZ)
ENSULIZOLE (UNII: 9YQ9DI1W42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
INULIN (UNII: JOS53KRJ01)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77462-009-05	200 g in 1 BOTTLE; 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(77462-009)