BEAUTY BALM- titanium dioxide, octinoxate lotion

BEAUTY BALM by

Drug Labeling and Warnings

BEAUTY BALM by is a Otc medication manufactured, distributed, or labeled by Modern Basic Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

titanium dioxide, 9%

ethylhexyl methoxycinnamate, 2%

purpose:

- suncreen

- helps prevent sunburn

- if used as directed with other sun protection measures (see directions), it decreases the risk of skin cancer and early skin aging caused by the sun

when using:

- For external use only
- Do not use on damaged or broken skin

- When using this product keep out of eyes

- Remove with water and mild cleanser

do not use:

- do not use on damaged or broken skin

ask doctor:

- stop use and ask doctor if rash occurs

keep out of reach of children

- keep out of reach of children. if swallowed, get medical help or contact a poison control center right away

Directions

*apply liberally 15 minutes before sun exposure

*reapply at least every 2 hours:

*after 40 minutes of swimming or sweating

*immediately after towel drying

*Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging, To decrease risk, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

*limit time in the sun, especially from 10am-2 pm

*wearlong-sleeved shirts, pants, hats and sunglasses

*children under 6 months of age: Ask a doctor

inactive ingredients:

Aqua, Cyclopentasiloxane, Disteardimonium Hectorite, Propylene Carbonate,Butylene Glycol , Dimethicone,Isotridecyl Isononanoate ,Glycerin ,Dicaprylyl Carbonate ,Isopropyl Myristate ,Hexyl Laurate , Cetyl PEG/PPG-10/1 Dimethicone, Polymethyl Methacrylate,Disodium EDTA ,Sodium Chloride ,Magnesium Sulfate ,Sodium Hyaluronate ,Methylparaben ,Propylparaben ,Sorbitan Sesquioleate ,Polyglyceryl-4 Isostearate ,PEG-10 Dimethicone ,Magnesium Stearate,Magnesium Palmitate ,Tocopheryl Acetate ,Propylene Glycol, Diazolidinyl Urea,Iodopropynyl Butylcarbamate, CI 77491, CI 77492, CI 77499

other information:

store this product in a cool place away from heat and direct sunlight

questions:

call toll free 1-877-438-1120

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEAUTY BALM 
titanium dioxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71305-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM PALMITATE (UNII: JJ0UR696JR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71305-600-10	30 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2018	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018	11/01/2020

Labeler - Modern Basic Cosmetics Ltd (208909999)