Label: BALI BODY TINTED SUPER SERUM TAN SPF 30- octisalate, octocrylene, titanium dioxide, zinc oxide lotion
BALI BODY TINTED SUPER SERUM NATURAL SPF 30- octisalate, octocrylene, titanium dioxide, zinc oxide lotion
- NDC Code(s): 70630-0031-1, 70630-0032-1
- 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 March 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients:- Natural Shade
- Active ingredients - Tan Shade
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally 15 mins before sun exposure.
- Shake well to activate.
- Apply 2-3 drops onto your fingertips & blend evenly all over the face & neck.
- Reapply at least every 2 hours
- 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am - 2pm
- Wear long sleeve shirts, pants, hats and sunglasses
- Children under 6 months: Ask a doctor.
-
Inactive ingredients - Natural Shade
Caprylyl Methicone, Water (Aqua), C12-15 Alkyl Benzoate, Lauryl PEG/PPG-18/18 Methicone, Dimethicone, Caprylic/Capric Triglyceride, Pentylene Glycol, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Dimethiconol, Sodium Chloride, Polyhydroxystearic Acid, Jojoba Esters, Silica, Mica, Polyglyceryl-3 Beeswax, Triethoxycaprylylsilane, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Sodium Stearoyl Glutamate, Citrus Aurantium Dulcis (Orange) Peel Oil, Boswellia Carterii Oil, Hydrogen Dimethicone, Tin Oxide, Limonene, Caprylyl Glycol, Glycerin, Hyaluronic Acid, Phenoxyethanol, Tocopheryl Acetate, Ethylhexylglycerin, Diaminopropionoyl Tripeptide-33, Glycine, Glutamic Acid, Serine, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Phenylalanine, Tyrosine, Isoleucine, Proline, Threonine, Valine, Histidine, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
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Inactive ingredients - Tan Shade
Water (Aqua), Caprylyl Methicone, C12-15 Alkyl Benzoate, Lauryl PEG/PPG-18/18 Methicone, Dimethicone, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Polyhydroxystearic Acid, Sodium Chloride, Dimethiconol, Jojoba Esters, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica, PEG/PPG-18/18 Dimethicone, Polyglyceryl-3 Beeswax, Triethoxycaprylylsilane, Sodium Stearoyl Glutamate, Hydrogen Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Oil, Boswellia Carterii Oil, Tin Oxide, Limonene, Caprylyl Glycol, Hyaluronic Acid, Glycerin, Tocopheryl Acetate, Phenoxyethanol, Diaminopropionoyl Tripeptide-33, Ethylhexylglycerin, Glycine, Glutamic Acid, Serine, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Phenylalanine, Tyrosine, Isoleucine, Proline, Threonine, Valine, Histidine, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
- Other information
- Product Packaging - Natural Shade
- Product Packaging - Tan Shade
-
INGREDIENTS AND APPEARANCE
BALI BODY TINTED SUPER SERUM TAN SPF 30
octisalate, octocrylene, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 78 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 56 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ORANGE OIL (UNII: AKN3KSD11B) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLUTAMIC ACID (UNII: 3KX376GY7L) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HYALURONIC ACID (UNII: S270N0TRQY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ASPARTIC ACID (UNII: 30KYC7MIAI) LEUCINE (UNII: GMW67QNF9C) LYSINE (UNII: K3Z4F929H6) PHENYLALANINE (UNII: 47E5O17Y3R) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) MICA (UNII: V8A1AW0880) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PENTYLENE GLYCOL (UNII: 50C1307PZG) FRANKINCENSE OIL (UNII: 67ZYA5T02K) STANNOUS OXIDE (UNII: JB2MV9I3LS) GLYCERIN (UNII: PDC6A3C0OX) GLYCINE (UNII: TE7660XO1C) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) WATER (UNII: 059QF0KO0R) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) FERRIC OXIDE RED (UNII: 1K09F3G675) ALANINE (UNII: OF5P57N2ZX) TYROSINE (UNII: 42HK56048U) PROLINE (UNII: 9DLQ4CIU6V) ARGININE (UNII: 94ZLA3W45F) ISOLEUCINE (UNII: 04Y7590D77) THREONINE (UNII: 2ZD004190S) VALINE (UNII: HG18B9YRS7) HISTIDINE (UNII: 4QD397987E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LIMONENE, (+)- (UNII: GFD7C86Q1W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) SERINE (UNII: 452VLY9402) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0032-1 1 in 1 BOX 07/31/2023 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/31/2023 BALI BODY TINTED SUPER SERUM NATURAL SPF 30
octisalate, octocrylene, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70630-0031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 81 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 31 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 32 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 59 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ORANGE OIL (UNII: AKN3KSD11B) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLUTAMIC ACID (UNII: 3KX376GY7L) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HYALURONIC ACID (UNII: S270N0TRQY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ASPARTIC ACID (UNII: 30KYC7MIAI) LEUCINE (UNII: GMW67QNF9C) LYSINE (UNII: K3Z4F929H6) PHENYLALANINE (UNII: 47E5O17Y3R) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) MICA (UNII: V8A1AW0880) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PENTYLENE GLYCOL (UNII: 50C1307PZG) FRANKINCENSE OIL (UNII: 67ZYA5T02K) STANNOUS OXIDE (UNII: JB2MV9I3LS) GLYCERIN (UNII: PDC6A3C0OX) GLYCINE (UNII: TE7660XO1C) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) WATER (UNII: 059QF0KO0R) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) FERRIC OXIDE RED (UNII: 1K09F3G675) ALANINE (UNII: OF5P57N2ZX) TYROSINE (UNII: 42HK56048U) PROLINE (UNII: 9DLQ4CIU6V) ARGININE (UNII: 94ZLA3W45F) ISOLEUCINE (UNII: 04Y7590D77) THREONINE (UNII: 2ZD004190S) VALINE (UNII: HG18B9YRS7) HISTIDINE (UNII: 4QD397987E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LIMONENE, (+)- (UNII: GFD7C86Q1W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) SERINE (UNII: 452VLY9402) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70630-0031-1 1 in 1 BOX 07/31/2023 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/31/2023 Labeler - Bali Body Pty Ltd (757840223)
