FDA.reportPublic FDA data

AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International, Inc.
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:35

Label at a glance#

ProductJAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and 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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredients                            Purpose    

OTC - ACTIVE INGREDIENT SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

SPL UNCLASSIFIED SECTION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-328-01JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES1 in 1 CARTONCREAM11
68828-328-01JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES50 mL in 1 TUBECREAM501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-32868828-328-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
CETYL ALCOHOL936JST6JCNIACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ARGININE94ZLA3W45FIACT
LEVOMENOL24WE03BX2TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CELLULOSE ACETATE3J2P07GVB6IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM7FLD91C86KIACT
PANTHENOLWV9CM0O67ZIACT
AMMONIO METHACRYLATE COPOLYMER TYPE B161H3B14U2IACT
PROPYLENE GLYCOL MONOSTEARATEMZM1I680W0IACT
MAGNESIUM STEARATE70097M6I30IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
COUMARINA4VZ22K1WTIACT
BENZYL BENZOATEN863NB338GIACT
LINALOOL, (+/-)-D81QY6I88EIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
EUROPEAN ELDERBERRYBQY1UBX046IACT
TOCOPHEROLR0ZB2556P8IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.cf33c5a1-b7c5-4c5a-9981-e4e24208cd112026-04-15WarningsExact identifier
ndc (package): 68828-328-01
ndc (product): 68828-328
ndc11 (package): 68828032801
spl id: 4f86347a-933b-8ff6-e063-6294a90a59c9
spl set id: cf33c5a1-b7c5-4c5a-9981-e4e24208cd11

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.