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

Bali Body BB Cream SPF 15 by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

BALI BODY BB CREAM SPF 15 
octinoxate, octocrylene, ocybenzone, avobenzone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-1605
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-1605-1	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2016
2	NDC: 70630-1605-2	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2016
3	NDC: 70630-1605-3	3 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/08/2016

Labeler - Bali Body Pty Ltd (757840223)

Registrant - Bali Body Pty Ltd (757840223)