Label: BEBAK SUN PROTECTION- octinoxate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 77462-008-05 - Packager: SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 16, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
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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.
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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
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INGREDIENTS AND APPEARANCE
BEBAK SUN PROTECTION
octinoxate sprayProduct 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)
