RIMMEL BB BEAUTY BALM MEDIUM- avobenzone, octinoxate, octisalate and octocrylene liquid

Rimmel BB Beauty Balm by

Drug Labeling and Warnings

Rimmel BB Beauty Balm by is a Otc medication manufactured, distributed, or labeled by Rimmel Inc., Lancaster S.A.M.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Avobenzone 3%

Octinoxate 4%

Octisalate 4%

Octocrylene 2%

PURPOSE

Sunscreen

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.

INDICATIONS & USAGE

• Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

For external use only.

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.

DOSAGE & ADMINISTRATION

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours

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

• Limit tim in the sun, especially from 10 a.m-2p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Aqua/Water/Eau, Dicaprylyl Carbonate, Mica, Cyclopentasiloxane, Glycerin, Behenyl Alcohol, Alcohol, Isodecyl Neopentanoate, Butyrospermum Parkii (Shea) Butter, Methyl Methacrylate Crosspolymer, Beheneth-25, Glyceryl Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Dimyristate, Ascorbyl Glucoside, BHT, Citric Acid, Disodium Stearoyl Glutamate, Clycyrrhiza Glabra (Licorice) Root Extract, Pentylene Glycol, Tetrasodium EDTA, Tocopherol, Triethoxycarpylylsilane, Xanthan Gum, Phenoxyethanol, Parfum/Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

BB Cream Medium Front Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RIMMEL BB BEAUTY BALM  MEDIUM
avobenzone, octinoxate, octisalate and octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76485-1025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.9 mL  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.2 mL  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.2 mL  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.6 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
DOCOSANOL (UNII: 9G1OE216XY)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
SHEA BUTTER (UNII: K49155WL9Y)
METHYL METHACRYLATE (UNII: 196OC77688)
BEHENETH-25 (UNII: 0G17KJ5M7P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76485-1025-1	30 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/15/2012

Labeler - Rimmel Inc. (949791073)

Establishment
Name	Address	ID/FEI	Business Operations
Lancaster S.A.M.		401011325	manufacture(76485-1025)