Label: BALI BODY FACE AND BODY SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene aerosol
- NDC Code(s): 70630-0024-1
- Packager: Bali Body Pty Ltd
- 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 February 16, 2022
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- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- Shake well before use. Hold bottle 4-5 inches away from your body & spray a generous amount to exposed dry skin.
- Apply liberally 15 minutes before sun exposure
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 80 minutes
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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Inactive ingredients
Dimethyl Ether, Water, Beeswax, 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.
- Other information
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INGREDIENTS AND APPEARANCE
BALI BODY FACE AND BODY SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0024 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 18 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHYL ETHER (UNII: AM13FS69BX) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL DIMETHICONE 45 (UNII: IK315POC44) ALOE VERA WHOLE (UNII: KIZ4X2EHYX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) YELLOW WAX (UNII: 2ZA36H0S2V) PEG-15 COCAMINE (UNII: 8L6LB12TSJ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCO-GLYCERIDES (UNII: ISE9I7DNUG) PEG-40 STEARATE (UNII: ECU18C66Q7) PHENOXYETHANOL (UNII: HIE492ZZ3T) SACCHARIDE ISOMERATE (UNII: W8K377W98I) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) TROLAMINE (UNII: 9O3K93S3TK) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0024-1 1 in 1 BOX 02/22/2022 1 175 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/22/2022 Labeler - Bali Body Pty Ltd (757840223)
