ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 IVORY- homosalate, 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.

----------

Always Foundation Makeup Broad Spectrum SPF 15 Ivory

Active Ingredients

Homosalate 4.25% Purpose Sunscreen

Octisalate 4.75% Purpose Sunscreen

Zinc Oxide 7.0% Purpose 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

Stop use and ask a doctor if rash occurs

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

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 a 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

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

Protect this product from excessive heat and direct sun

JAFRA beauty

Always

Foundation Makeup

Broad Spectrum SPF 15

30 ML e 1 FL OZ (US)

599UCFondationMakeupSPF15

ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 IVORY 
homosalate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-424
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
KAOLIN (UNII: 24H4NWX5CO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-424-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/20/2020
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-424)

Revised: 8/2020
Document Id: adb6a1c7-ec75-5489-e053-2995a90a80fe
Set id: adb6a1c7-ec74-5489-e053-2995a90a80fe
Version: 1
Effective Time: 20200825
 
JAFRA COSMETICS INTERNATIONAL