Label: TREAT AND TINT SKIN PERFECTING BB SPF 30- octinoxate octisalate avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54754-101-12, 54754-101-22 - Packager: SORME COMPANY INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 6, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
DIRECTIONS
- APPLY AS THE LAST STEP AFTER SKIN CARE AND MAKEUP PRIMER, IF DESIRED. WEAR ALONE OR UNDER FOUNDATION.
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
- 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 BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER MEASURES INCLUDING:
- LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
- REAPPLY AT LEAST EVERY 2 HOURS.
- USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- PEDIATRIC USE
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INACTIVE INGREDIENT
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 SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TREAT AND TINT SKIN PERFECTING BB SPF 30
octinoxate octisalate avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54754-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:54754-101-22 1 in 1 BOX 1 NDC:54754-101-12 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/06/2013 Labeler - SORME COMPANY INC (836119933) Establishment Name Address ID/FEI Business Operations MICRO CONNECTION ENTERPRISES INC 144297160 manufacture(54754-101)
