MATTIFYING DAY MOISTURE BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octisalate, octocrylene, oxybenzone cream

Mattifying Day Moisture Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Mattifying Day Moisture Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients         Purpose

Avobenzone 2.75%      Sunscreen

Octisalate 5%               Sunscreen

Octocrylene 7.5%         Sunscreen

Oxybenzone  2%          Sunscreen

Uses
 helps prevent sunburn
 If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children

Stop use and ask a doctor if rash occurs.

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.

Directions

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months: Ask a doctor
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 sun protection measures
including:
   limit time in the sun, especially from 10 a.m. - 2 p.m.
   wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Water/Aqua, Aluminum, Starch Octenylsuccinate, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Biosaccharide Gum-1, Azadirachta Indica Extract, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, Butylene Glycol, Decamethylcyclopentasiloxane, Fragrance/Parfum, DMDM Hydantoin, Panthenol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Trisodium EDTA, Tocopherol, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Avena Sativa (Oat) Kernel Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 20, Ethoxylated Castor Oil, Cistus Incanus Extract, Maltodextrin, Lysine Thiazolidine Carboxylate

PRINCIPAL DISPLAY PANEL

Jafra advanced dynamics mattifying

day moisture broad spectrum SPF 15

with Advanced Intellishield+

for oil skin

50 ml 1.7 FL OZ

INGREDIENTS AND APPEARANCE

MATTIFYING DAY MOISTURE BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.75 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
AZADIRACHTA INDICA BARK (UNII: G580B439YI)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SWEET POTATO (UNII: M9WGG9Z9GK)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PANTHENOL (UNII: WV9CM0O67Z)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
EDETATE TRISODIUM (UNII: 420IP921MB)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
OAT (UNII: Z6J799EAJK)
TEA TREE OIL (UNII: VIF565UC2G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CISTUS INCANUS FLOWERING TOP (UNII: N7Z341R6CA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)
LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-180-02	1 in 1 CARTON	11/26/2013
1	NDC: 68828-180-01	50 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 68828-180-04	1 in 1 CARTON	11/26/2013
2	NDC: 68828-180-03	7.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 68828-180-06	1 in 1 CARTON	11/26/2013
3	NDC: 68828-180-05	2 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/26/2013

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-180)