JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone,homosalate,octisalate,octocrylene liquid

JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN by

Drug Labeling and Warnings

JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Distribuidora Comercial Jafra, S.A. de C.V., Jafra Cosmetics International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 10%

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

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep 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.

KEEP OUT OF REACH OF CHILDREN

Directions

• shake before use 
• apply liberally and evenly 15 minutes before sun exposure 
• reapply at least every 2 hours 
• use a water resistant sunscreen if swimming or sweating 
• 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, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Styrene/Acrylates Copolymer, Caprylyl Methicone, C13-15 Alkane, C12-15 Alkyl Benzoate, Di-PPG-3 Myristyl Ether Adipate, Phenyl Trimethicone, Silica, Petroleum Distillates, Propanediol, Sodium Chloride, Vinyl Dimethicone Crosspolymer, Aluminum Starch Octenylsuccinate, Phenoxyethanol, VP/Hexadecene Copolymer, Disteardimonium Hectorite, Propylene Carbonate, Lactic Acid, Xanthan Gum, Ethylhexylglycerin, Tocopheryl Acetate, Silica Dimethyl Silylate, Inulin, Glycerin, Lecithin

SPL UNCLASSIFIED SECTION

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

Product label

INGREDIENTS AND APPEARANCE

JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone,homosalate,octisalate,octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-601
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
C13-15 ALKANE (UNII: 114P5I43UJ)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
XANTHAN GUM (UNII: TTV12P4NEE)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
INULIN (UNII: JOS53KRJ01)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-601-01	1 in 1 CARTON	06/01/2025
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2025

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(68828-601)