TREAT AND TINT SKIN PERFECTING BB SPF 30- octinoxate octisalate avobenzone cream

TREAT AND TINT SKIN PERFECTING BB by

Drug Labeling and Warnings

TREAT AND TINT SKIN PERFECTING BB by is a Otc medication manufactured, distributed, or labeled by SORME COMPANY INC, MICRO CONNECTION ENTERPRISES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

OCTINOXATE (6.0%)

OCTISALATE (4.5%)

AVOBENZONE (1.5%)

PURPOSE

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

USES

• HELPS PREVENT SUNBURN
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES, DECREASES THE RISK OF SKIN CANCER AND SKIN AGING CAUSED BY THE SUN.

WARNINGS

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

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

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

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

CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

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

OTHER INFORMATION

PROTECT PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS

QUESTIONS OR COMMENTS?

CALL TOLL FREE 800-927-6763

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TREAT AND TINT SKIN PERFECTING BB  SPF 30
octinoxate octisalate avobenzone cream

Product 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)