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

JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREEN by

Drug Labeling and Warnings

JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 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 7%
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

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

SPL UNCLASSIFIED SECTION

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

Product label

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-602
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: 68828-602-01	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(68828-602)