FDA.reportPublic FDA data

JAFRA ROYAL REVITALIZE 4 TUBE SET

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics international Inc.
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:14

Label at a glance#

ProductJAFRA ROYAL REVITALIZE 4 TUBE SET
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 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 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Purpose

OTC - PURPOSE SECTION

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 use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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 your time in the sun, especially from 10 a.m. – 2 p.m.

        • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis (Kiwi) Fruit Water, Alcohol, Allantoin,

Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol,

Butyrospermum Parkii (Shea) Butter, Chlorphenesin, Cocos Nucifera Fruit Extract, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA,

Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, Moringa Oleifera

Leaf Extract, PEG-100 Stearate, Phenethyl Alcohol, Polygonum Aviculare Extract, Royal Jelly,

Sodium Ascorbyl Phosphate, Sophora Flavescens Root Extract, Styrene/Acrylates Copolymer, Tetrapeptide-45, Water/Aqua

Other information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
68828-522-01JAFRA ROYAL REVITALIZE 4 TUBE SET1 in 1 KITKIT12
68828-523-01JAFRA ROYAL REVITALIZE 4 TUBE SET14 mL in 1 TUBELOTION14 mL5 g in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-522JAFRA ROYAL REVITALIZE 4 TUBE SET (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]2Current NDC, 2 package rows20250112_b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98.zip
68828-523JAFRA ROYAL REVITALIZE 4 TUBE SET (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]2Unmatched20250112_b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98.zip

Products#

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

DailyMed product names page 1 of 3 · 92 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-52268828-522-01
68828-52368828-523-01

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 141 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
PEG-7 GLYCERYL COCOATEVNX7251543INGR
COCO GLUCOSIDEICS790225BINGR
DECYL GLUCOSIDEZ17H97EA6YINGR
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AINGR
SODIUM LAUROYL SARCOSINATE632GS99618INGR
GLYCOL STEARATE0324G66D0EINGR
PHENOXYETHANOLHIE492ZZ3TINGR
SODIUM HYDROXIDE55X04QC32IINGR
ALLANTOIN344S277G0ZINGR
EDETATE SODIUMMP1J8420LUINGR
BENZOIC ACID8SKN0B0MIMINGR
DEHYDROACETIC ACID2KAG279R6RINGR
CAPRYLYL GLYCOL00YIU5438UINGR
SODIUM ASCORBYL PHOSPHATE836SJG51DRINGR
GLYCERINPDC6A3C0OXINGR
POLYGONUM AVICULARE TOPZCD6009IUFINGR
ROYAL JELLYL497I37F0CINGR
SHEA BUTTERK49155WL9YINGR
DIPROPYLENE GLYCOLE107L85C40INGR
LECITHIN, SOYBEAN1DI56QDM62INGR
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NINGR
PHENYLETHYL ALCOHOLML9LGA7468INGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
MALTODEXTRIN7CVR7L4A2DINGR
LIMONENE, (+)-GFD7C86Q1WINGR
HYDROXYCITRONELLAL8SQ0VA4YURINGR
BUTYLPHENYL METHYLPROPIONALT7540GJV69INGR
LINALOOL, (+/-)-D81QY6I88EINGR
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EINGR
WATER059QF0KO0RINGR
OCTYLDODECANOL461N1O614YINGR
BIOSACCHARIDE GUM-1BB4PU4V09HINGR
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
ROYAL JELLYL497I37F0CINGR
KIWI FRUIT OIL66086CWP3QINGR
DMDM HYDANTOINBYR0546TOWINGR
COCONUT3RT3536DHYINGR

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 ROYAL REVITALIZE 4 TUBE SETAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca982025-01-09WarningsExact identifier
ndc (package): 68828-523-01
ndc (package): 68828-522-01
ndc (product): 68828-522
ndc11 (package): 68828052301
ndc11 (package): 68828052201
spl id: 2b45ed23-0c0b-1b2b-e063-6294a90adcc5
spl set id: b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98

Reported adverse events (FAERS/openFDA)#

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