ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA- octinoxate, 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.

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Always Foundation Makeup Broad Spectrum SPF 15 Cocoa

Active Ingredients Purpose

Octinoxate 3% Sunscreen

Zinc Oxide 6.8% 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

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

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
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours.
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 a Broad-Spectrum SPF value of 15 or higher and other sun
protection measures including:

• limit your time in the sun, especially from 10
a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

• Children under 6 months of age: ask a doctor.

Inactive ingredients

C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, Dimethicone Crosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcocoate PEG-8 Dimethicone, Iron Oxides/CI 77491/CI 77492/CI 77499, Kaolin, Lecithin, Methicone, Phenoxyethanol, Phenyl Trimethicone, Propylene carbonate, Silica, Silica Dimethyl Silylate, Sodium Chloride, Stoddard solvent, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Water/Aqua

Jafra beauty

always

Foundation Makeup Broad Spectrum SPF 15 Cocoa

30 ml 1 FL OZ (US)

UCFoundMakeupSPF15

ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-421
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.8 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHICONE (20 CST) (UNII: 6777U11MKT)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
KAOLIN (UNII: 24H4NWX5CO)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-421-0130 mL in 1 CARTON; Type 0: Not a Combination Product07/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/14/2020
Labeler - Jafra Cosmetics International (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-421)

Revised: 7/2020
Document Id: aaabb449-eee5-bb74-e053-2a95a90a4476
Set id: aaabb449-eee6-bb74-e053-2a95a90a4476
Version: 1
Effective Time: 20200717
 
Jafra Cosmetics International