FDA.reportPublic FDA data

MediumCC creme Broad Spectrum SPF 15

Manufacturer
Jafra Cosmetics International | Jafra Manufacturing, S.A. de C.V
Effective date
2019-05-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:59:33

Label at a glance#

ProductMediumCC creme Broad Spectrum SPF 15 JAFRA
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active

ingredients                   Purpose

Zinc Oxide 6.8% ......... 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 product is 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

  • 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 of sweating
  • reapply at least every 2 hours
  • children under 6 months: 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, regularyl use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Water/Aqua, Cyclopentasiloxane, PEG/PPG-18/18 Dimethicone, Cyclomethicone, Caprylic Capric Triglyceride, Polyhyroxystearic Acid, Propanediol, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Iron Oxides/ CI 77491/CI 77492/CI 77499, Methicone, Glycerin, Sodium Chloride, Sodium Dehydroacetate, DMDM Hydantoin, Palmitic Acid, Disodium EDTA, Dextrin, Palmitate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Cucumis Sativus Extract, Glycrrhiza Glabra Extract, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medium

Jafra

CC Creme

Broad Spectrum SPF 15

30 ml / 1 FL OZ (US)

BoxBox

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-236-022022-01-28C16284748780-1d6a99b39-d20f-a426-e053-dadaa90af4c2CC Creme Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-236-01MediumCC creme Broad Spectrum SPF 15JAFRA30 mL in 1 TUBECREAM304
68828-236-02MediumCC creme Broad Spectrum SPF 15JAFRA1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-236MEDIUMCC CREME BROAD SPECTRUM SPF 15 JAFRA (ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]4Legacy NDC, 2 package rows20190529_52378e92-b386-453d-a4a6-cc1ab49aed97.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC CATIONACTIVE MOIETY13S1S8SF371
BORON NITRIDEINACTIVE INGREDIENT2U4T60A6YD1
CUCUMBERINACTIVE INGREDIENTYY7C30VXJT1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKT1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H11
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM01
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1Z1
PEG/PPG-18/18 DIMETHICONEINACTIVE INGREDIENT9H0AO7T7941
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971G1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-23668828-236-01, 68828-236-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
CYCLOMETHICONENMQ347994ZIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
BORON NITRIDE2U4T60A6YDIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
METHICONE (20 CST)6777U11MKTIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
DMDM HYDANTOINBYR0546TOWIACT
PALMITIC ACID2V16EO95H1IACT
EDETATE DISODIUM7FLD91C86KIACT
PEG-4 LAURATEAYF4VM3N1ZIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
CUCUMBERYY7C30VXJTIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 413 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRABURSAL0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RECTALNAExact identifier — unii candidate
134 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
10 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii candidate
5 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZSOLUTION / TOPICAL11.57 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRASYNOVIAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVENOUS28773 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRATHECAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates

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
4e90deb5-914c-4942-9334-63d6604d049152378e92-b386-453d-a4a6-cc1ab49aed972019-05-28WarningsExact identifier
spl id: 4e90deb5-914c-4942-9334-63d6604d0491
spl set id: 52378e92-b386-453d-a4a6-cc1ab49aed97

Reported adverse events (FAERS/openFDA)#

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