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 
Bali Body Pty Ltd

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.

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Bali Body Tinted Super Serum SPF 30

Drug Facts

Active ingredients:- Natural Shade

Octisalate 3.1%

Octocrylene 8.1%

Titanium Dioxide 3.2%

Zinc Oxide 5.9%

Active ingredients - Tan Shade

Octisalate 4.9%

Octocrylene 7.8%

Titanium Dioxide 3.1%

Zinc Oxide 5.6%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Please refer to balibodyco.com for further sun safety instructions.

Directions

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:

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)

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

natural

Product Packaging - Tan Shade

Tan

BALI BODY TINTED SUPER SERUM TAN SPF 30 
octisalate, octocrylene, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE78 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE56 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0032-11 in 1 BOX07/31/2023
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/31/2023
BALI BODY TINTED SUPER SERUM NATURAL SPF 30 
octisalate, octocrylene, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE81 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE31 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE59 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0031-11 in 1 BOX07/31/2023
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/31/2023
Labeler - Bali Body Pty Ltd (757840223)

Revised: 3/2023
Document Id: f8237e63-f80c-47c7-e053-6394a90a6056
Set id: f5eeaf37-33f2-2c0c-e053-2a95a90abcc0
Version: 2
Effective Time: 20230330
 
Bali Body Pty Ltd