JAFRA SUN TINTED FACE PROTECTOR SUNSCREEN BROAD SPECTRUM 50- avobenzone, homosalate, octisalate, octocrylene cream

Jafra Sun tinted face protector sunscreen broad spectrum 50 by

Drug Labeling and Warnings

Jafra Sun tinted face protector sunscreen broad spectrum 50 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics Internationl, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients        Purpose

Avobenzone 3%..............Sunscreen

Homosalate 10%.............Sunscreen

Octisalate 5%..................Sunscreen

Octocrylene 10%.............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

INDICATIONS & USAGE

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.
• Stop use and ask a doctor ifrash occurs.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• reapply:

        after 40 minutes of swimming or sweating
        immediately after towel drying
        at least every 2 hours

• Children under 6 months of age: 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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Polyester-8, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Titanium Dioxide, Arginine, Iron Oxides, Bisabolol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Tocopheryl Acetate, Fragrance, Cellulose Acetate, Disodium EDTA, Panthenol, Benzyl Salicylate, Acrylates /Ammonium Methacrylate Copolymer, Ethylhexylglycerin, Propylene Glycol Stearate, Coumarin, Butylphenyl Methylpropional, Linalool, Magnesium Stearate, Hydroxycitronellal, Sambucus Nigra (Elderberry) Fruit Extract

SPL UNCLASSIFIED SECTION

Questions?Call 1-800-551-2345 or visit www .jafra.com

Product label

INGREDIENTS AND APPEARANCE

JAFRA SUN TINTED FACE PROTECTOR SUNSCREEN BROAD SPECTRUM 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-293
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-100 STEARATE (UNII: YD01N1999R)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ARGININE (UNII: 94ZLA3W45F)
LEVOMENOL (UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
COUMARIN (UNII: A4VZ22K1WT)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-293-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021
2	NDC: 68828-293-02	7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/14/2021

Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra cosmetics international Inc. (031183599)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-293)