RIMMEL BB BEAUTY BALM MEDIUM DARK- avobenzone, octinoxate, octisalate and octocrylene liquid 
Rimmel Inc.

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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Drug Facts

Drug Facts

Avobenzone 3%

Octinoxate 4%

Octisalate 4%

Octocrylene 2%

Sunscreen

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

For sunscreen use:

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:

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)

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RIMMEL BB BEAUTY BALM  MEDIUM DARK
avobenzone, octinoxate, octisalate and octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76485-1026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9 mL  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.2 mL  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.2 mL  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.6 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76485-1026-130 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/15/2012
Labeler - Rimmel Inc. (949791073)
Establishment
NameAddressID/FEIBusiness Operations
Lancaster S.A.M.401011325manufacture(76485-1026)

Revised: 10/2012
Document Id: e8275f1d-9373-4c7a-899e-ea0df170b96d
Set id: 6bc8d64e-ee11-4068-b006-c3e1afb355b5
Version: 1
Effective Time: 20121018
 
Rimmel Inc.