OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Octinoxate 7.49%
Oxybenzone 2%
Active Ingredients: Octinoxate 7.49%
Oxybenzone 2%
Warnings: Avoid contact with the eyes. For external use only.
Keep out of reach of children. Discontinue use if signs
of irritation or rash appear. Contains Oxybenzone.
PRINCIPAL DISPLAY PANEL
Fresh
SUGAR
ROSE TINTED LIP TREATMENT SPF 15
4.3 g 0.15oz
Fresh Inc Boston 02118 USA
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49817-1988-4 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d8fb-8e05-e053-dbdaa90a074a | 92ca04d5-6f41-4f06-bd17-6747199ab018 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49817-1988 | FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK [GUERLAIN] | 2 | Legacy NDC | 20110103_92ca04d5-6f41-4f06-bd17-6747199ab018.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| 1-Decanol | INACTIVE INGREDIENT | 89V4LX791F | 2 | |
| Alpha-Tocopherol | INACTIVE INGREDIENT | H4N855PNZ1 | 2 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | 2 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | 2 | |
| Avocado Oil | INACTIVE INGREDIENT | 6VNO72PFC1 | 2 | |
| Butylated Hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| Carnauba Wax | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| Castor Oil | INACTIVE INGREDIENT | D5340Y2I9G | 2 | |
| D&C Red No. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 2 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 2 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| Grape Seed Oil | INACTIVE INGREDIENT | 930MLC8XGG | 2 | |
| Isostearic Acid | INACTIVE INGREDIENT | X33R8U0062 | 2 | |
| Jojoba Oil | INACTIVE INGREDIENT | 724GKU717M | 2 | |
| Meadowfoam Seed Oil | INACTIVE INGREDIENT | 412ZHA4T4Y | 2 | |
| Polyglycerin-3 | INACTIVE INGREDIENT | 4A0NCJ6RD6 | 2 | |
| Propyl Gallate | INACTIVE INGREDIENT | 8D4SNN7V92 | 2 | |
| Ribes Nigrum Seed Oil | INACTIVE INGREDIENT | GKE1188837 | 2 | |
| Ricinoleic Acid | INACTIVE INGREDIENT | I2D0F69854 | 2 | |
| Rosa Damascena Flower | INACTIVE INGREDIENT | JWB78P295A | 2 | |
| Sunflower Oil | INACTIVE INGREDIENT | 3W1JG795YI | 2 | |
| Tetrahexyldecyl Ascorbate | INACTIVE INGREDIENT | 9LBV3F07AZ | 2 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| Vitamin A Palmitate | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 | |
| White Wax | INACTIVE INGREDIENT | 7G1J5DA97F | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49817-1988 | 49817-1988-8, 49817-1988-4 |
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 |
|---|---|---|---|---|---|---|
| Castor Oil | CASTOR OIL | D5340Y2I9G | TABLET / ORAL | 17 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| Alpha-Tocopherol | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| D&C Red No. 7 | D&C RED NO. 7 | ECW0LZ41X8 | CAPSULE / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SYRUP / ORAL | 4 mg/5ml | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| White Wax | WHITE WAX | 7G1J5DA97F | CAPSULE / ORAL | 79 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| Ferrosoferric Oxide | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | FILM / SUBLINGUAL | 0.03 mg | ||
| Ferrosoferric Oxide | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| D&C Red No. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / VAGINAL | 0.05 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| Propyl Gallate | PROPYL GALLATE | 8D4SNN7V92 | CREAM / TOPICAL | NA | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| D&C Red No. 7 | D&C RED NO. 7 | ECW0LZ41X8 | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| White Wax | WHITE WAX | 7G1J5DA97F | AEROSOL, FOAM / TOPICAL | 2 %w/w | ||
| White Wax | WHITE WAX | 7G1J5DA97F | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| White Wax | WHITE WAX | 7G1J5DA97F | TABLET, DELAYED RELEASE / ORAL | 0.08 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| Ascorbyl Palmitate | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| Isostearic Acid | ISOSTEARIC ACID | X33R8U0062 | CREAM / TOPICAL | 100 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | LOTION / TOPICAL | 1000 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| Castor Oil | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| Ferrosoferric Oxide | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| D&C Red No. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET, COATED / ORAL | NA | ||
| White Wax | WHITE WAX | 7G1J5DA97F | OINTMENT, AUGMENTED / TOPICAL | 429 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| Aluminum Oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| Propyl Gallate | PROPYL GALLATE | 8D4SNN7V92 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| Propyl Gallate | PROPYL GALLATE | 8D4SNN7V92 | TABLET / ORAL | 7 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / RECTAL | 1 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| Alpha-Tocopherol | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 850cf12e-7152-4bfc-82fa-d882cd7d5ad2 | 92ca04d5-6f41-4f06-bd17-6747199ab018 | 2010-12-31 | Warnings | 850cf12e-7152-4bfc-82fa-d882cd7d5ad2 92ca04d5-6f41-4f06-bd17-6747199ab018 |
Adverse event summaries are temporarily unavailable. Other product information remains available.