Label: BONDI SANDS FRAGRANCE FREE SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene aerosol, spray
- NDC Code(s): 79950-001-01
- Packager: BONDI SANDS (USA) INC.
- Category: HUMAN OTC DRUG LABEL
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 August 14, 2020
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- Official Label (Printer Friendly)
- 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.
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Other information
- Avoid spraying in eyes.
- Contents under pressure.
- Do not puncture or incinerate.
- Do not store at temperature above 120 °F.
- Use only as directed.
- Protect the product in this container from excessive heat and direct sun.
- You may report a serious adverse reaction to 888-266-0772; Monday – Friday, 9 am – 5 pm.
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Inactive Ingredients
Dimethyl Ether, Water/Aqua/Eau, Beeswax/Cera Alba/Cire d'abeille, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cocoglycerides, Glycerin, PEG-15 Cocamine, 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 FRAGRANCE FREE SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79950-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 18 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 48 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 60 mg in 1 g Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) DIMETHYL ETHER (UNII: AM13FS69BX) 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:79950-001-01 160 g in 1 CAN; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2021 Labeler - BONDI SANDS (USA) INC. (117596864)
