FDA.reportPublic FDA data

defy time protector moisturizer broad spectrum SPF 15

Manufacturer
Jafra Cosmetics International | Jafra Manufacturing S.A. de C.V.
Effective date
2019-05-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:59:30

Label at a glance#

Productdefy time protector moisturizer broad spectrum SPF 15 Jafra time dynamics
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                     Purpose

Octinoxate  7.5%                         Sunscreen

Zinc Oxide  3%                            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 Contol 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 increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum of SPF 15 or higher and other sun protection measures including:

     limit time in the sun, especially from 10a.m - 2p.m.

     wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water/Aqua, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, Dimethicone, Glycerin, Triticum Vulgare (Wheat) Germ Protein, Avena Sativa (Oat) Kernel Protein,Saccharide lsomerate, Polyacrylamide, C13-141soparaffin, Laureth-7, Panthenol, DMDM Hydantoin, Diazolidinyl Urea, Biosaccharide Gum-4, Lecithin,Tocopheryl Acetate, Caprylic/Capric Triglylceride, Ubiquinone, Diisopropyl Adipate, Alcohol, Chondrus Crispus (Carrageenan) Extract, Chlorella Vulgaris Extract, Phytosterol lsostearate, Allantoin, Retinyl Palmitate, Ascorbyl Methylsilanol Pectinate, Trisodium EDTA, PEG-4 Laurate, lodopropynyl Bulylcarbamate, Propylene Glycol, Camellia Sinensis Leal Extract, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Smithsonite Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jafra

time dynamics defy

Time protector Moisturizer broad spectrum SPF 15

50ml 1.7fl oz

cartoncarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-201-022022-01-28C16284748780-1d6a99b39-84a7-a426-e053-dadaa90af4c2476b3bcd-6da8-4b9c-b60a-e35e862afc9c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-201-01defy time protector moisturizer broad spectrum SPF 15Jafra time dynamics50 mL in 1 JARCREAM504
68828-201-02defy time protector moisturizer broad spectrum SPF 15Jafra time dynamics1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-201DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA TIME DYNAMICS (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]4Legacy NDC, 2 package rows20190523_476b3bcd-6da8-4b9c-b60a-e35e862afc9c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ALLANTOININACTIVE INGREDIENT344S277G0Z2
ASCORBYL METHYLSILANOL PECTINATEINACTIVE INGREDIENTM3PF9237YC2
BIOSACCHARIDE GUM-4INACTIVE INGREDIENT9XRL057X902
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE702
CERAMIDE 3INACTIVE INGREDIENT4370DF050B2
CHLORELLA VULGARISINACTIVE INGREDIENTRYQ4R60M022
CHONDRUS CRISPUS CARRAGEENANINACTIVE INGREDIENTUE856F2T782
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW42
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72X2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW2
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB2
LAURETH-7INACTIVE INGREDIENTZ95S6G82012
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM622
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1Z2
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWV2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SACCHARIDE ISOMERATEINACTIVE INGREDIENTW8K377W98I2
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD2
TRIDECYL NEOPENTANOATEINACTIVE INGREDIENT3Z8H1DA7J52
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M462
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
WATERINACTIVE INGREDIENT059QF0KO0R2
WHEAT GERMINACTIVE INGREDIENTYR3G369F5A2

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-20168828-201-01, 68828-201-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
TRIDECYL NEOPENTANOATE3Z8H1DA7J5IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
WHEAT GERMYR3G369F5AIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
PANTHENOLWV9CM0O67ZIACT
DMDM HYDANTOINBYR0546TOWIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
BIOSACCHARIDE GUM-49XRL057X90IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
UBIDECARENONEEJ27X76M46IACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
ALCOHOL3K9958V90MIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
CHLORELLA VULGARISRYQ4R60M02IACT
ALLANTOIN344S277G0ZIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ASCORBYL METHYLSILANOL PECTINATEM3PF9237YCIACT
EDETATE TRISODIUM420IP921MBIACT
PEG-4 LAURATEAYF4VM3N1ZIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SOYBEANL7HT8F1ZODIACT
CERAMIDE 34370DF050BIACT

Source Document#

Source XML

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 5 · 279 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XAEROSOL, FOAM / TOPICAL200 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
DIISOPROPYL ADIPATEDIISOPROPYL ADIPATEP7E6YFV72XSOLUTION / TOPICAL815 mgExact identifier — unii candidate
7 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii candidate
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 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
9dd21f21-8eb4-4927-a3f0-7565d5f87cc8476b3bcd-6da8-4b9c-b60a-e35e862afc9c2019-05-21WarningsExact identifier
spl id: 9dd21f21-8eb4-4927-a3f0-7565d5f87cc8
spl set id: 476b3bcd-6da8-4b9c-b60a-e35e862afc9c

Reported adverse events (FAERS/openFDA)#

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