Bali Body BB Cream SPF 15 Natural

Bali Body BB Cream SPF 15 Natural by

Drug Labeling and Warnings

Bali Body BB Cream SPF 15 Natural by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BALI BODY BB CREAM SPF 15 NATURAL- 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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Bali Body BB Cream SPF 15 Natural

Product Information / Drug Facts

Directions:

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

Warnings:

For external use only. Keep out of direct sunlight or other sources of strong light. Product to be stored between 5-28°C. Discontinue 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 balibodyyco.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:

Sunscreen

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, Butylene Glycol, BHT, Fragrance (Parfum), Sodium hydroxide, Phenoxyethanol, Benzyl Alcohol, Ethylhexylglycerin, Potassium Sorbate, Mica, Iron Oxides (CI 77492, CI 77491, CI 77499), Titanium Dioxide (CI 77891)

Package Labeling:

BALI BODY BB CREAM SPF 15 NATURAL 
octocrylene, octinoxate, avobenzone, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	49.95 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0017-1	1 in 1 BOX	04/30/2021
1		35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/30/2021	02/09/2024

Labeler - Bali Body Pty Ltd (757840223)

Revised: 3/2022

Document Id: db496783-c5b5-1dc0-e053-2995a90a9ce2

34390-5

Set id: 8df2e938-0a7c-42af-8fca-230e04215b2c

Version: 4

Effective Time: 20220328