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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	49 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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 70630-0013-1	1 in 1 BOX	01/01/2021
1		35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2021	08/01/2021

Labeler - Bali Body Pty Ltd (757840223)

Revised: 12/2021

Document Id: d28f1e77-cc97-c3da-e053-2995a90a9b51

Set id: 05d1ced9-99d0-4765-bd9f-5c8db5c2a1f6

Version: 2

Effective Time: 20211207