CONTROL DYNAMICS MATTIFYING SPF 15- octinoxate octisalate oxybenzone lotion

CONTROL DYNAMICS MATTIFYING by

Drug Labeling and Warnings

CONTROL DYNAMICS MATTIFYING 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, AZADIRACHTA INDICA EXTRACT, TAGETUS ERECTA (AFRICN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, BUTYLENE GLYCOL, ALUMINUM STARCH OCTENYLSUCCINATE, SODIUM POLYACRYLATE, HYDROGENATED POLYDECENE, TRIDECETH-6, LYSINE CARBOXYMETHYL CYSTEINATE, LYSINE THIAZOLIDINE CARBOXYLATE, DECAMETHYLCYCLOPENTASILOXANE, SACCHARIDE ISOMERATE, MALIC ACID, HYDROLYZED PRUNUS AMGDALUS DULCIS (SWEET ALMOND) PROTEIN, PANTHENOL, PROPYLENE GLYCOL, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, BIOSACCHARIDE GUM-4, BUTYL AVOCADATE, CHONDRUS CRISPUS, (CARRAGEENAN) EXTRACT, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, POLYSORBATE 20, ETHOXYLATED CASTOR OIL, BLUE 1/CI 42090, YELLOW 5/CI 19140 [FRAGRANCE/PARFUM CONTAINS: BUTYLPHENYL METHYLPROPIONAL (LILLIAL), COUMARIN,  LIMONENE, LINALOOL, HEXYL CINNAMAL]

INDICATIONS & USAGE

MATTIFYING LOTION SPF 15

INSTRUCTIONS FOR USE

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

WARNINGS

CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

STOP USE

DISCONTINUE USE IF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

JAFRA

CONTROL DYNAMICS

MATTIFYING LOTION SPF 15

  

  

INGREDIENTS AND APPEARANCE

CONTROL DYNAMICS MATTIFYING  SPF 15
octinoxate octisalate oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-158
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AZADIRACHTA INDICA BARK (UNII: G580B439YI)
TAGETES ERECTA FLOWER (UNII: UH5X33P33E)
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
CYSTEINE, DL- (UNII: 5CM45Q5YAF)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
MALIC ACID (UNII: 817L1N4CKP)
ALMOND (UNII: 3Z252A2K9G)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
PERSEA AMERICANA LEAF (UNII: 8490RQ2BET)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
GINGER (UNII: C5529G5JPQ)
LEVOMENOL (UNII: 24WE03BX2T)
TEA TREE OIL (UNII: VIF565UC2G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYOXYL 60 CASTOR OIL (UNII: VXP26NM2XX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-158-12	1 in 1 BOX
1	NDC: 68828-158-62	50 mL in 1 BOTTLE
2	NDC: 68828-158-27	1 in 1 BOX
2	NDC: 68828-158-17	7 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/14/2012

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