Label: BONDI SANDS FRAGRANCE FREE FACE SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79950-006-01
- 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 14, 2020
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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, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Saccharide Isomerate, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Sodium Chloride, Citric Acid.
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INGREDIENTS AND APPEARANCE
BONDI SANDS FRAGRANCE FREE FACE SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79950-006 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 80 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) SACCHARIDE ISOMERATE (UNII: W8K377W98I) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) YELLOW WAX (UNII: 2ZA36H0S2V) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TROLAMINE (UNII: 9O3K93S3TK) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79950-006-01 75 mL in 1 TUBE; 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)