Tan BB Cream SPF15 by Bali Body Pty Ltd Tan BB Cream SPF15

Tan BB Cream SPF15 by

Drug Labeling and Warnings

Tan BB Cream SPF15 by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TAN BB CREAM SPF15- octocrylene, octinoxate, avobenzone, oxybenzone cream 
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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Tan BB Cream SPF15

Product Information / Drug Facts

Directions:

Apply to clean skin with fingertips. Layer for additional coverage.

Warnings:

For external use only. Keep out of direct sunlight or other sources of strong light. Product to be stored beteen 5-28°C. Discontinues use if irritation occurs. Subtle variations in appearance and texture of this product in no way affect its integrity.

Keep out of reach of children.

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

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

Octocrylene 6%
Octinoxate 4.9%
Avobenzone 3%
Oxybenzone 3%

Purpose:

Sunsreen

Inactive ingredients:

Water (Aqua), Propylene Glycol, Ethylhexyl Stearate, Cyclopentasiloxane, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Tapioca Starch, Cyclohexasiloxane, Cetearyl Alcohol, Potassium Cetyl Phosphate, Cetearyl Olivate, Glycerin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Hydrolyzed Collagen, Sorbitan Olivate, Phytic Acid, Butylene Glycol, BHT, Fragrance (Parfum), Sodium Hydroxide, Phenoxyethanol, Benzyl Alcohol, Ethyylhexylglycerin, Potassium Sorbate, Mica, Iron Oxides CI 77492, CI 77491, CI 77499, Titanium Dioxide (CI77891)

Package Labeling:

Bottle13

TAN BB CREAM SPF15 
octocrylene, octinoxate, avobenzone, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70630-0013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE49 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ELEUTHERO (UNII: ZQH6VH092Z)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70630-0013-11 in 1 BOX01/01/2021
135 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/202108/01/2021
Labeler - Bali Body Pty Ltd (757840223)

Revised: 12/2021
 

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