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

Bali Body BB Cream SPF 15 Tan by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 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 6.0%

Octinoxate 5.0%

Oxybenzone 3.0%

Avobenzone 3.0%

Purpose:

Sunscreen

Inactive ingredients:

Water (Aqua), Propylene Glycol, Cyclopentasiloxane, Ethylhexyl Stearate, Glyceryl Stearate, Cetearyl Alcohol, Tapioca Starch, Vitis Vinifera (Grape) Seed Oil, Cyclohexasiloxane, Potassium Cetyl Phosphate, Glycerin, CI 77891, Cl 77492, Cetearyl Olivate, Sorbitan Olivate, Phenoxyethanol, Mica, Benzyl Alcohol, Ethylhexylglycerin, Phytic Acid, Sodium Hydroxide, Butylene Glycol, Hydrolyzed Collagen, Sodium Hyaluronate, Acanthopanax Senticosus Root Extract, Camellia Sinensis Leaf Extract, Alcohol, Fragrance (Parfum), Potassium Sorbate, Cl 77491, Cl 77499.

Package Labeling:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0030
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	50 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
FYTIC ACID (UNII: 7IGF0S7R8I)
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)
ALCOHOL (UNII: 3K9958V90M)
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: 70630-0030-1	1 in 1 BOX	03/25/2022
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	03/25/2022

Labeler - Bali Body Pty Ltd (757840223)