Label: BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79950-012-01
- 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 5, 2021
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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.
- Other information
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Inactive Ingredients
Water, Beeswax, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cyclopentasiloxane, Isopropyl Palmitate, Ceteareth-20, Cyclohexasiloxane, Hydroxyacetophenone, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Sodium Carrageenan, Sodium Chloride, Aminomethyl Propanediol.
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INGREDIENTS AND APPEARANCE
BONDI SANDS BROAD SPECTRUM HYDRA UV PROTECT SPF 70 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79950-012 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 150 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) PHENOXYETHANOL (UNII: HIE492ZZ3T) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARRAGEENAN (UNII: 5C69YCD2YJ) YELLOW WAX (UNII: 2ZA36H0S2V) SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZYL ALCOHOL (UNII: LKG8494WBH) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79950-012-01 150 mL in 1 TUBE; Type 0: Not a Combination Product 08/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/05/2021 Labeler - BONDI SANDS (USA) INC. (117596864)