CALMING DYNAMICS

Manufacturer
JAFRA COSMETICS INTERNATIONAL | Jafra Manufacturing, S.A. de C.V.
Effective date
2012-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:31:48

Label at a glance#

ProductCALMING DYNAMICS SPF 15
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

OTC - PURPOSE SECTION

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: WATER/AQUA, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, TRIDECYL NEOPENTANOATE, ALUMINUM STARCH OCTENYLSUCCINATE, SACCHARIDE ISOMERATE, BUTYLENE GLYCOL, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LURETH-7, HEMIDESMUS INDICUS EXTRACT, PHYLLANTHUS EMBLICA EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, DIMETHICONE, PUERARIA LOBATA ROOT EXTRACT, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID.

INDICATIONS & USAGE SECTION

GENTLE HYDRATING DAY CREAM SPF 15

DOSAGE & ADMINISTRATION SECTION

TO USE: IN THE MORNING AFTER CLEANSING, SMOOTH OVER FACE AND THROAT.

WARNINGS SECTION

DISCONTINUE USE IF IRRITATION OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAFRA

CALMING DYNAMICS

GENTLE HYDRATING DAY CREAM SPF 15


Calming Dynamics SPF-15_ART_Box-FR_50mLCalming Dynamics SPF-15_ART_Box-FR_50mL


Calming Dynamics SPF-15_ART_Box-BK_50mLCalming Dynamics SPF-15_ART_Box-BK_50mL

Calming Dynamics SPF-15_ART_LBL-FR_50mLCalming Dynamics SPF-15_ART_LBL-FR_50mL   Calming Dynamics SPF-15_ART_LBL-BK_50mLCalming Dynamics SPF-15_ART_LBL-BK_50mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-055-122020-01-31C16284748780-19d75b9d0-4921-f424-e053-dadaa90a57ceCALMING DYNAMICS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-055-12CALMING DYNAMICSSPF 151 in 1 BOXCREAM12
68828-055-62CALMING DYNAMICSSPF 1550 mL in 1 JARCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-055CALMING DYNAMICS SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]2Legacy NDC, 2 package rows20120515_0a02cd3f-0d10-4b74-8545-e7e11f202c0c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O62942
BIOSACCHARIDE GUM-1INACTIVE INGREDIENTBB4PU4V09H2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE702
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1X2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H2
HEMIDESMUS INDICUS ROOTINACTIVE INGREDIENTY5CFT48S902
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ42
HYDROXYPHENYL PROPAMIDOBENZOIC ACIDINACTIVE INGREDIENT25KRT26H772
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB2
LAURETH-7INACTIVE INGREDIENTZ95S6G82012
OATINACTIVE INGREDIENTZ6J799EAJK2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1Z2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG2
PHYLLANTHUS EMBLICA FRUITINACTIVE INGREDIENTYLX4CW25762
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2I2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M2
PUERARIA MONTANA VAR. LOBATA ROOTINACTIVE INGREDIENTPET93F4I3C2
SACCHARIDE ISOMERATEINACTIVE INGREDIENTW8K377W98I2
SQUALANEINACTIVE INGREDIENTGW89575KF92
TRIDECYL NEOPENTANOATEINACTIVE INGREDIENT3Z8H1DA7J52
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68828-05568828-055-62, 68828-055-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

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 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / VAGINAL0.03 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
CHONDRUS CRISPUSCHONDRUS CRISPUSOQS23HUA1XLOTION / TOPICALNAExact identifier — unii candidate
SQUALANESQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
ALUMINUM STARCH OCTENYLSUCCINATEALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294CREAM / TOPICAL321 mgExact identifier — unii candidate
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii candidate
SQUALANESQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii candidate
13 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9POWDER / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 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
9cbcd855-2de2-48c1-b4b7-143d94ba9a6c0a02cd3f-0d10-4b74-8545-e7e11f202c0c2012-05-14WarningsExact identifier
spl id: 9cbcd855-2de2-48c1-b4b7-143d94ba9a6c
spl set id: 0a02cd3f-0d10-4b74-8545-e7e11f202c0c

Reported adverse events (FAERS/openFDA)#

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