Label: BALI BODY HYDRATING FACE SUNSCREEN SPF50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 70630-0026-1
- 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 25, 2022
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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:
- At least every 80 minutes
- 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 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
Water, Cocoglycerides, Cetyl Dimethicone, Silica, PEG-15 Cocamine, Stearyl Behenate, Glycerin, C12-15 Alkyl Benzoate, PEG-40 Stearate, Polyhydroxystearic Acid, Tocopheryl Acetate, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Triethanolamine, Aloe Barbadensis Extract.
- Other information
- Company Information
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INGREDIENTS AND APPEARANCE
BALI BODY HYDRATING FACE SUNSCREEN SPF50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL DIMETHICONE 45 (UNII: IK315POC44) ALOE VERA WHOLE (UNII: KIZ4X2EHYX) STEARYL BEHENATE (UNII: A68S9UI39D) 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) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) TROLAMINE (UNII: 9O3K93S3TK) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0026-1 1 in 1 BOX 02/25/2022 1 50 mL in 1 BOTTLE, PUMP; 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 02/25/2022 Labeler - Bali Body Pty Ltd (757840223)
