JAFRA BIOLAB SUNSCREENS AND CLEANSER- avobenzone,homosalate,octisalate,octocrylene kit

JAFRA BIOLAB SUNSCREENS AND CLEANSER by

Drug Labeling and Warnings

JAFRA BIOLAB SUNSCREENS AND CLEANSER 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)

Part 2: JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL CREAM BROAD SPECTRUM SPF 30 SUNSCREEN

Avobenzone 3%
Homosalate 7%
Octisalate 5%
Octocrylene 10%

Part 3: JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50+ SUNSCREEN
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

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

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

Part 2: JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL CREAM BROAD SPECTRUM SPF 30 SUNSCREEN
Water, Niacinamide, C12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Potassium Cetyl Phosphate, Caprylyl Methicone, Silica, C13-15 Alkane, Hydrogenated Palm Glycerides, Cetearyl Alcohol, VP/Hexadecene Copolymer, Phenoxyethanol, Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dicetyl Phosphate, Ceteth-10 Phosphate, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Tocopheryl Acetate, Ethylhexylglycerin, Inulin, Epigallocatechin Gallatyl Glucoside, Glycerin, Lecithin

Part 3: JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50+ SUNSCREEN
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 SUNSCREENS AND CLEANSER 
avobenzone,homosalate,octisalate,octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-603

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-603-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	06/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	2 mL
Part 2	1 POUCH	2 mL
Part 3	1 POUCH	2 mL

Part 1 of 3

DARK SPOT CORRECTOR FACIAL SERUM 
skin fresheners [skin care preparations (creams, lotions, powder, and sprays)]

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	GLYCERETH-26 (UNII: NNE56F2N14)
INGR	BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
INGR	PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
INGR	MAGNESIUM ASPARTATE (UNII: R17X820ROL)
INGR	ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
INGR	INULIN (UNII: JOS53KRJ01)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	EPIGALLOCATECHIN GALLATYL GLUCOSIDE (UNII: AR8RR3M6N9)
INGR	TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)
INGR	COPPER GLUCONATE (UNII: RV823G6G67)
INGR	SOYBEAN LECITHIN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 in 1 CARTON
1		2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 2 of 3

JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL CREAM BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone,homosalate,octisalate,octocrylene cream

Product Information
Item Code (Source)	NDC: 68828-604
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	7 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)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
C13-15 ALKANE (UNII: 114P5I43UJ)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
XANTHAN GUM (UNII: TTV12P4NEE)
INULIN (UNII: JOS53KRJ01)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
EPIGALLOCATECHIN GALLATYL GLUCOSIDE (UNII: AR8RR3M6N9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-604-01	2 mL in 1 POUCH; 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

Part 3 of 3

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

Product Information
Item Code (Source)	NDC: 68828-605
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: 68828-605-01	2 mL in 1 POUCH; 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

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(68828-603, 68828-604, 68828-605)