Label: BONDI SANDS SPORT SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79950-015-01
- Packager: BONDI SANDS (USA) INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 26, 2022
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- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours.
- 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 Broad 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.
- Children under 6 months: Ask a doctor.
- Other information
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Inactive Ingredients
Water/Aqua/Eau, Beeswax/Cera Alba/Cire d'abeille, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cocoglycerides, PEG-15 Cocamine, Glycerin, PEG-40 Stearate, Phenoxyethanol, Saccharide Isomerate, Caprylyl Glycol, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Caprylhydroxamic Acid, Tocopheryl Acetate, Aloe Barbadensis Extract, Citric Acid, Sodium Citrate, Potassium Sorbate, Sodium Benzoate.
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INGREDIENTS AND APPEARANCE
BONDI SANDS SPORT SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79950-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) YELLOW WAX (UNII: 2ZA36H0S2V) PEG-15 COCAMINE (UNII: 8L6LB12TSJ) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIDE ISOMERATE (UNII: W8K377W98I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO-GLYCERIDES (UNII: ISE9I7DNUG) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ALOE VERA WHOLE (UNII: KIZ4X2EHYX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PEG-40 STEARATE (UNII: ECU18C66Q7) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL DIMETHICONE 45 (UNII: IK315POC44) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79950-015-01 300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/03/2022 Labeler - BONDI SANDS (USA) INC. (117596864)
