TREAT AND TINT SKIN PERFECTING BB SPF 30- octinoxate octisalate avobenzone cream 
SORME COMPANY 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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ACTIVE INGREDIENTS

OCTINOXATE (6.0%)

OCTISALATE (4.5%)

AVOBENZONE (1.5%)

PURPOSE

SUNSCREEN

USES

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.

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

INACTIVE INGREDIENTS

WATER, GLYCERIN, STEARIC ACID, VP/EICOSENE COPOLYMER, OCTYLDODECANOL, QUATERNIUM 18, HECTORITE, PROPYLENE CARBONATE, CYCLOPENTASILOXANE, POLYSORBATE 60, PENTAERYTHRITYL TETRAETHYLHEXANOATE, CETYL ALCOHOL, STEARYL ALCOHOL, PHENYL TRIMETHICONE, SORBITAN STEARATE, DIMETHICONE, BUTYLENE GLYCOL, CAPRYLYL METHICONE, POLYSILICONE 11, CETYL ESTERS, CAPRYLYL GLYCOL, PHENOXYETHANOL, HEXYLENE GLYCOL, STEARYL ALCOHOL, CETEARETH 20, CAMELLIA SINESIS LEAF EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, ALOE BARBADENSIS (ALOE) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT, PANAX GINSENG ROOT EXTRACT, PASSIFLORA INCARNATA (PASSION FRUIT) EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ARGANIA SPINOSA (ARGAN) KERNEL OIL, SODIUM HYALURONATE, ETHYLHEXYLGLYCERIN, SODIUM ACRYLATE/ACRYLOYDIMETHYL TAURATE, ISOHEXADECANE, POLYSORBATE 80, XANTHAN GUM, SODIUM HYDROXIDE, TOCOPHEROL. MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77489, CI 77491, CI 77492, CI 77499), MICA (CI 77019).

OTHER INFORMATION

PROTECT PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS OR COMMENTS?

CALL TOLL FREE 800-927-6763

BBcream

Sorme BB Cream_SPF30USA-R44

TREAT AND TINT SKIN PERFECTING BB  SPF 30
octinoxate octisalate avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54754-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PVP/VA COPOLYMER (UNII: D9C330MD8B)  
OCTYLDECANOL (UNII: 07UG7TSU58)  
QUATERNIUM-18 (UNII: O7757NO1VL)  
HECTORITE (UNII: 08X4KI73EZ)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CETEARETH-22 (UNII: 28VZG1E234)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)  
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
ARGAN OIL (UNII: 4V59G5UW9X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54754-101-221 in 1 BOX
1NDC:54754-101-1250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/06/2013
Labeler - SORME COMPANY INC (836119933)
Establishment
NameAddressID/FEIBusiness Operations
MICRO CONNECTION ENTERPRISES INC144297160manufacture(54754-101)

Revised: 1/2013
Document Id: d6393e4f-fd08-460e-9398-f09026983b33
Set id: 2a00e54c-b302-42eb-a192-a2af5f420a4b
Version: 1
Effective Time: 20130106
 
SORME COMPANY INC