LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 NUDE JAFRA- octisalate, zinc oxide cream 
JAFRA COSMETICS INTERNATIONAL

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.

----------

Long Wear Makeup Broad Spectrum SPF 20 Nude

Active

Ingredients          Purpose

Octisalate 3% ...... Sunscreen

Zinc Oxide 6.8% .... Sunscreen

Uses

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Warnings

Directions

Water/Aqua, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Phenyl Triemthicone, C12-15 Alkyl Benzoate, Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Squalane,Boron Nitride, Synthetic Fluorophlogopite, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Sodium Hyaluronate, Butylene Glycol, Glycyrrhiza Glabra (Licorice) Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymehtylsilsesquioxane, Lentinus Edodes (shiitake) Extract, Ipomoea Batatas Tuber Extract, Centella Asiatica Extract, Withania Somniferia Extract, Butylene Glycol, Biosaccharide Gum-4, Smithsonite Extact, Chondrus Crispus (Carrageenan) Extract, Triethoxycaprylylsilane [May Containt +/-: Titanium Dioxide, Iron Oxides/ CI 77492/ CI 77491/ CI 77499]

JAFRA

Long Wear Makeup

Broad Spectrum SPF 20

30 ml / 1 FL oz (us)

Box

LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 NUDE  JAFRA
octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SQUALANE (UNII: GW89575KF9)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
RICE BRAN (UNII: R60QEP13IC)  
ROSEMARY (UNII: IJ67X351P9)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LICORICE (UNII: 61ZBX54883)  
LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)  
SWEET POTATO (UNII: M9WGG9Z9GK)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
WITHANIA SOMNIFERA LEAF (UNII: J337CNM3CW)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-263-021 in 1 BOX02/21/2017
1NDC:68828-263-0130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/21/2017
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-263)

Revised: 6/2020
Document Id: 4cdf08b4-10e2-452d-9f61-831062a0969a
Set id: 8d84cfba-f961-4df9-a7df-4ebba5cd592b
Version: 3
Effective Time: 20200623
 
JAFRA COSMETICS INTERNATIONAL