OTC - ACTIVE INGREDIENT SECTION
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3
PURPOSE: SUNSCREEN
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.
GENTLE HYDRATING DAY CREAM SPF 15
TO USE: IN THE MORNING AFTER CLEANSING, SMOOTH OVER FACE AND THROAT.
DISCONTINUE USE IF IRRITATION OCCURS.
KEEP OUT OF REACH OF CHILDREN.
JAFRA
CALMING DYNAMICS
GENTLE HYDRATING DAY CREAM SPF 15
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68828-055-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4921-f424-e053-dadaa90a57ce | CALMING DYNAMICS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68828-055-12 | CALMING DYNAMICSSPF 15 | 1 in 1 BOX | CREAM | 1 | 2 | |
| 68828-055-62 | CALMING DYNAMICSSPF 15 | 50 mL in 1 JAR | CREAM | 50 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| ALUMINUM STARCH OCTENYLSUCCINATE | INACTIVE INGREDIENT | I9PJ0O6294 | 2 | |
| BIOSACCHARIDE GUM-1 | INACTIVE INGREDIENT | BB4PU4V09H | 2 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 2 | |
| CHONDRUS CRISPUS | INACTIVE INGREDIENT | OQS23HUA1X | 2 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 2 | |
| GLYCYRRHIZA GLABRA | INACTIVE INGREDIENT | 2788Z9758H | 2 | |
| HEMIDESMUS INDICUS ROOT | INACTIVE INGREDIENT | Y5CFT48S90 | 2 | |
| HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) | INACTIVE INGREDIENT | 86FQE96TZ4 | 2 | |
| HYDROXYPHENYL PROPAMIDOBENZOIC ACID | INACTIVE INGREDIENT | 25KRT26H77 | 2 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 2 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 2 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 2 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 2 | |
| PEG-4 LAURATE | INACTIVE INGREDIENT | AYF4VM3N1Z | 2 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 2 | |
| PHYLLANTHUS EMBLICA FRUIT | INACTIVE INGREDIENT | YLX4CW2576 | 2 | |
| POLYACRYLAMIDE (10000 MW) | INACTIVE INGREDIENT | E2KR9C9V2I | 2 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 2 | |
| PUERARIA MONTANA VAR. LOBATA ROOT | INACTIVE INGREDIENT | PET93F4I3C | 2 | |
| SACCHARIDE ISOMERATE | INACTIVE INGREDIENT | W8K377W98I | 2 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 2 | |
| TRIDECYL NEOPENTANOATE | INACTIVE INGREDIENT | 3Z8H1DA7J5 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68828-055 | 68828-055-62, 68828-055-12 |
Every source-derived ingredient row is available through these pages.
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / TOPICAL | 2.85 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / VAGINAL | 0.03 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | LOTION / TOPICAL | 5 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | EMULSION / ORAL | 20 mg/1ml | ||
| CHONDRUS CRISPUS | CHONDRUS CRISPUS | OQS23HUA1X | LOTION / TOPICAL | NA | ||
| SQUALANE | SQUALANE | GW89575KF9 | SOLUTION / TOPICAL | 1 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| ALUMINUM STARCH OCTENYLSUCCINATE | ALUMINUM STARCH OCTENYLSUCCINATE | I9PJ0O6294 | CREAM / TOPICAL | 321 mg | ||
| DMDM HYDANTOIN | DMDM HYDANTOIN | BYR0546TOW | LOTION / TOPICAL | 3 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | CREAM, AUGMENTED / TOPICAL | 120 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / RECTAL | 0.05 mg/mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / VAGINAL | 200 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | POWDER / ORAL | 0.02 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | AEROSOL, FOAM / TOPICAL | 2.23 %w/w | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | OINTMENT / TOPICAL | 2 %w/w | ||
| SQUALANE | SQUALANE | GW89575KF9 | CREAM / TOPICAL | 6 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | GUM, CHEWING / BUCCAL | 5 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SHAMPOO / TOPICAL | 14.55 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | TABLET, COATED / ORAL | NA | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / ORAL | 125 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | AEROSOL, FOAM / TOPICAL | 30 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9cbcd855-2de2-48c1-b4b7-143d94ba9a6c | 0a02cd3f-0d10-4b74-8545-e7e11f202c0c | 2012-05-14 | Warnings | 9cbcd855-2de2-48c1-b4b7-143d94ba9a6c 0a02cd3f-0d10-4b74-8545-e7e11f202c0c |
Adverse event summaries are temporarily unavailable. Other product information remains available.