Label: BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 FACE FLUID- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79950-013-01
- Packager: BONDI SANDS (USA) INC.
- 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 August 10, 2021
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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. Use a water resistant sunscreen if swimming or sweating.
- 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, Beeswax, C12-15 Alkyl Benzoate, Silica, PEG-15 Cocamine, Caprylyl Glycol, PEG-40 Stearate, Acrylates/Steareth-20 Methacrylate Copolymer, Caprylhydroxamic Acid, Glycerin, Carbomer, Aminomethyl Propanol, Phenoxyethanol, Sodium Carrageenan, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Sodium Chloride.
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INGREDIENTS AND APPEARANCE
BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 FACE FLUID
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79950-013 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 120 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-15 COCAMINE (UNII: 8L6LB12TSJ) CARRAGEENAN (UNII: 5C69YCD2YJ) YELLOW WAX (UNII: 2ZA36H0S2V) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) PEG-40 STEARATE (UNII: ECU18C66Q7) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79950-013-01 1 in 1 CARTON 08/10/2021 1 40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/10/2021 Labeler - BONDI SANDS (USA) INC. (117596864)
