FDA.reportPublic FDA data

Solar Protection Fluid Broad Spectrum SPF 50

Manufacturer
JAFRA COSMETICS INTERNATIONAL | Jafra Manufacturing, S.A. de C.V
Effective date
2020-06-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:22

Label at a glance#

ProductSolar Protection Fluid Broad Spectrum SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients        Purpose

Avobenzone 3%         Sunscreen

Homosalate 10%        Suncreen

Octisalate 5%            Suncreen

Octocrylene 7%         Sunscreen

OTC - PURPOSE SECTION

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

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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: Ask a doctor
  • Sun Protection Measures. Spending time in the sun icreases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Specturm SPF 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Inactive ingredients

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/Acrylate Copolymer, Tetrapeptide-45, Water/Aqua

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAFRA

Royal Jelly

Solar Protection Fluid

Broad Spectrum SPF 50

50 ml   1.7 FL OZ (US)

CartonCarton

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-282-022022-01-28C16284748780-19d75b9cf-fa4f-f424-e053-dadaa90a57ceRoyal Jelly - Solar Protection Fluid Broad Spectrum SPF 50
68828-282-022020-06-11C16284748780-19d75b9cf-fa4f-f424-e053-dadaa90a57ceRoyal Jelly - Solar Protection Fluid Broad Spectrum SPF 50
68828-282-022020-01-31C16284748780-19d75b9cf-fa4f-f424-e053-dadaa90a57ceRoyal Jelly - Solar Protection Fluid Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-282-01Solar Protection Fluid Broad Spectrum SPF 5050 mL in 1 TUBECREAM502
68828-282-02Solar Protection Fluid Broad Spectrum SPF 501 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-282SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [JAFRA COSMETICS INTERNATIONAL]2Legacy NDC, 2 package rows20200612_c3ef7c5e-2b99-4a4a-bc05-fb6f022c078e.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-28268828-282-01, 68828-282-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
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
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML · Source PDF

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
a7d2fc10-1931-e7c5-e053-2995a90a7330c3ef7c5e-2b99-4a4a-bc05-fb6f022c078e2020-06-11WarningsExact identifier
spl id: a7d2fc10-1931-e7c5-e053-2995a90a7330
spl set id: c3ef7c5e-2b99-4a4a-bc05-fb6f022c078e

Reported adverse events (FAERS/openFDA)#

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