BALANCE DYNAMICS BALANCING SPF 15- octisalate oxybenzone octinoxate lotion

BALANCE DYNAMICS BALANCING by

Drug Labeling and Warnings

BALANCE DYNAMICS BALANCING by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE, OCTISALATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT

OTHER INGREDIENTS: WATER/AQUA, TRIBEHENIN PEG-20 ESTERS, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, CENTELLA ASIATICA EXTRACT, WITHANIA SOMNIFERIA EXTRACT, BUTYLENE GLYCOL, DIMETHICONE, DIMETHICONE CROSSPOLYMER, XYLITOL, XYLITAN, XYLITYL POLYGLUCOSIDE, GLYCERYL STEARATE, BIS-DIGLYCERYL POLYACRYLADIPATE-2, IRIS FLORENTINA ROOT EXTRACT, RETINYL PALMITATE, ZINC SULFATE, ALCOHOL, PROPYLENE GLYCOL, BIOSACCHARIDE GUM-1, LAMINARIA SACCHARINA EXTRACT, GLYCERIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, SILANEDIOL SALICYLATE, ACRYLATES COPOLYMER, CYCLOMETHICONE,  TRIETHANOLAMINE, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, BIOSACCHARIDE GUM-4, PANTHENOL, TOCOPHERYL  ACETATE, CARBOMER, XANTHAN GUM, FRAGRANCE/PARFUM, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, YELLOW 6/CI 15985, RED 33/CI 17200 [FRAGRANCE/PARFUM CONTAINS: AMYL CINNAMAL, BENZYL ALCOHOL, BENZYL BENZOATE, LIMONENE, LINALOOL, BUTYLCHEMYL METHYLPROPIONAL (LILLIAL)].

INDICATIONS & USAGE

BALANCING LOTION SPF 15

DOSAGE & ADMINISTRATION

TO USE: IN THE MORNING AFTER CLEANSING, SMOOTH OVER FACE AND THROAT.

WARNINGS

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

JAFRA

BALANCE

DYNAMICS

BALANCING LOTION SPF 15

INGREDIENTS AND APPEARANCE

BALANCE DYNAMICS BALANCING  SPF 15
octisalate oxybenzone octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
XYLITOL (UNII: VCQ006KQ1E)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIGLYCERIN (UNII: 3YC120743U)
IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ZINC SULFATE (UNII: 89DS0H96TB)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)
SHEA BUTTER (UNII: K49155WL9Y)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SILANETRIOL (UNII: E52D0J3TS5)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
CYCLOMETHICONE (UNII: NMQ347994Z)
TROLAMINE (UNII: 9O3K93S3TK)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE TRISODIUM (UNII: 420IP921MB)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GINGER (UNII: C5529G5JPQ)
LEVOMENOL (UNII: 24WE03BX2T)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-150-17	7 mL in 1 TUBE
2	NDC: 68828-150-12	1 in 1 BOX
2	NDC: 68828-150-62	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/24/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture