FDA.reportPublic FDA data

Jafra Royal Defy Travel Kit

Manufacturer
Distribuidora Comercial Jafra, S.A. de C.V. | Jafra Cosmetics International, Inc.
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:42:13

Label at a glance#

ProductRevitalize Solar Protection Fluid Broad Spectrum SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 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 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 protecti...

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 product keep 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 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 your 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, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Bisabolol, Behenyl Alcohol, Cyclopentasiloxane, Lauroyl Lysine, Fragrance, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Acrylates/Dimethicone Copolymer, Royal Jelly Powder, Glycerin, Benzyl Salicylate, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Sodium Ascorbyl Phosphate, Lecithin, Hydroxycitronellal, Limonene, Hydrogenated Lecithin, Linalool, Royal Jelly, Polygonum Aviculare Extract, Phenethyl Alcohol, Cocos Nucifera (Coconut) Fruit Extract, Butylene Glycol, Actinidia Chinensis (Kiwi) Fruit Water, Moringa Oleifera Leaf Extract, Maltodextrin, Tetrapeptide-45, Alcohol, Sophora Flavescens Root Extract

Questions?

SPL UNCLASSIFIED SECTION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-515-01Revitalize Solar Protection Fluid Broad Spectrum SPF 5050 mL in 1 TUBECREAM5010
68828-515-01Revitalize Solar Protection Fluid Broad Spectrum SPF 501 in 1 CARTONCREAM110

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-51568828-515-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
KIWI FRUIT OIL66086CWP3QIACT
ALCOHOL3K9958V90MIACT
ALLANTOIN344S277G0ZIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
ARGININE94ZLA3W45FIACT
DOCOSANOL9G1OE216XYIACT
BENZYL ALCOHOLLKG8494WBHIACT
LEVOMENOL24WE03BX2TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SHEA BUTTERK49155WL9YIACT
CHLORPHENESINI670DAL4SZIACT
COCONUT3RT3536DHYIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
LAUROYL LYSINE113171Q70BIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MALTODEXTRIN7CVR7L4A2DIACT
MORINGA OLEIFERA LEAF4WET1AWO9BIACT
PEG-100 STEARATEYD01N1999RIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
ROYAL JELLYL497I37F0CIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
WATER059QF0KO0RIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-01-17full-release2026-06-01 00:53:00

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
Revitalize Solar Protection Fluid Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.29b3ee35-e849-4427-a455-37d92c4b995c2025-11-05WarningsExact identifier
ndc (package): 68828-515-01
ndc (product): 68828-515
ndc11 (package): 68828051501
spl id: 42d817df-e34e-6e71-e063-6294a90a081b
spl set id: 29b3ee35-e849-4427-a455-37d92c4b995c

Reported adverse events (FAERS/openFDA)#

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