Solar Protection Fluid

Manufacturer
JAFRA COSMETICS INTERNATIONAL | Jafra Manufacturing, S.A. de C.V
Effective date
2018-02-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:54:22

Key Label Information#

Active Ingredients And Purpose

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

Uses

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

Warnings

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.

Directions And Dosage

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

Other Label Information

INACTIVE INGREDIENT SECTION

Water/Aqual, Styrene/Acrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethylhexylglycerin, Benzyl Alcohol, Bisabolol, Royal Jelly, Cyclopentasiloxane, Acrylates/Dimethicon Copolymer, Cocos Nucifera, Moringa Oleifera, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Cichorium Intybus (Chicory) Root Extract, Kappaphycus Alvarezii Extract, Glycerin, Polygonum Aviculare Extract, Sodium Ascorbyl Phosphate, Benzyl Salicylate, Limonene, Hydroxycitronellal, Butylphenyl Methylpropional (Lillial), Linalool

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAFRA Royal Jelly Solar Protection Fluid Broad Spectrum SPF 50 50 ml 1.7 FL OZ (US)

Label Images#

JRR-010UCJRRSolarProtectionSPF50US
JRR-010UCJRRSolarProtectionSPF50US

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-240-01Solar Protection FluidBroad Spectrum SPF 5050 mL in 1 TUBECREAM504
68828-240-02Solar Protection FluidBroad Spectrum SPF 501 in 1 BOXCREAM14
68828-240-03Solar Protection FluidBroad Spectrum SPF 501 mL in 1 PACKAGECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-240SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [JAFRA COSMETICS INTERNATIONAL]4Legacy NDC, 3 package rows20180205_13ffe33d-d8b4-41d8-94de-9dd243155d90.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VC1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O62941
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BU1
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJ1
ARGININEINACTIVE INGREDIENT94ZLA3W45F1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU1
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV691
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO1
CHICORY ROOTINACTIVE INGREDIENT090CTY533N1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
COCOS NUCIFERA WHOLEINACTIVE INGREDIENT245J88W96L1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDROXYCITRONELLALINACTIVE INGREDIENT8SQ0VA4YUR1
KAPPAPHYCUS ALVAREZIIINACTIVE INGREDIENTT479H08K2O1
LAUROYL LYSINEINACTIVE INGREDIENT113171Q70B1
LIMONENE, (+/-)-INACTIVE INGREDIENT9MC3I344471
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
MORINGA OLEIFERA WHOLEINACTIVE INGREDIENT5JH60A416W1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
POLYGONUM AVICULARE TOPINACTIVE INGREDIENTZCD6009IUF1
ROYAL JELLYINACTIVE INGREDIENTL497I37F0C1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DR1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-24068828-240-01, 68828-240-02, 68828-240-03

Ingredients#

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Suncreen Octisalate 5% Suncreen Octocrylene 7% Sunscreen

OTC - PURPOSE SECTION

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

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

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

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 INGREDIENT SECTION

Water/Aqual, Styrene/Acrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethylhexylglycerin, Benzyl Alcohol, Bisabolol, Royal Jelly, Cyclopentasiloxane, Acrylates/Dimethicon Copolymer, Cocos Nucifera, Moringa Oleifera, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Cichorium Intybus (Chicory) Root Extract, Kappaphycus Alvarezii Extract, Glycerin, Polygonum Aviculare Extract, Sodium Ascorbyl Phosphate, Benzyl Salicylate, Limonene, Hydroxycitronellal, Butylphenyl Methylpropional (Lillial), Linalool

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAFRA Royal Jelly Solar Protection Fluid Broad Spectrum SPF 50 50 ml 1.7 FL OZ (US)

Source Document#

Source XML