BALI BODY BB CREAM SPF 15- octinoxate, octocrylene, ocybenzone, avobenzone cream 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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Bali Body BB Cream SPF 15 (Available in 4 Shades)

BB Box PDP TanBB Box PDP Natural

Dark AWFair AW

Octinoxate 4%

Avobenzone 4%

Oxybenzone 3%

Octocrylene 2.7%

Keep out of reach of children.

A multi-tasking beauty cream.

Provides SPF 15 protection.

Shake well before use. Apply liberaly 15 minutes before sun exposure.

Children under 6 months old: Ask a doctor.

Re-apply every 2 hours.

Use water-resistant sunscreen if swimming or sweating.

Store in cool dry place.

Skin Cancer/Skin Ageing Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Always wear a hat, protective clothing and sunglasses.

Apply liberally 15 minutes before sun exposure.

BALI BODY BB CREAM SPF 15 
octinoxate, octocrylene, ocybenzone, avobenzone cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-1605
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE SEED OIL (UNII: 930MLC8XGG)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
FERROUS OXIDE (UNII: G7036X8B5H)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-1605-135 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/201608/31/2021
2NDC:70630-1605-235 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/201609/30/2022
3NDC:70630-1605-33 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/08/2016
Labeler - Bali Body Pty Ltd (757840223)
Registrant - Bali Body Pty Ltd (757840223)

Revised: 1/2021
Document Id: b8392126-4c49-de19-e053-2995a90a73e0
Set id: 9c6efc8e-f554-4982-892a-1c064073f15e
Version: 6
Effective Time: 20210106
 
Bali Body Pty Ltd