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 INGREDIENT

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

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

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

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

PURPOSE

• 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

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

INDICATIONS & USAGE

Stop use and ask a doctorif rash occurs.

WARNINGS

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

• 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 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

INACTIVE INGREDIENT

Acrylates/Ammonium Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Bisabolol, Cellulose Acetate, Cetyl Alcohol, Dicaprylyl Carbonate, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Iron Oxides/CI 77491/CI 77492/CI 77499, Magnesium Stearate, Propylene Glycol Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sambucus Nigra (Elderberry) Fruit Extract, Styrene/Acrylates Copolymer, Titanium Dioxide (CI 77891 ), Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

JAFRA

SUN

50+

tinted face protector suncreen broad spectrum SPF 50+

Water Resistant (40 minutes)

50 ml e 1.7 FL OZ (US)

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 ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ARGININE (UNII: 94ZLA3W45F)
LEVOMENOL (UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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

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

Labeler - Jafra Cosmetics Internationl (041676479)

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