OTC - ACTIVE INGREDIENT SECTION
Active Ingredient:
Salicylic Acid 0.5%
Active Ingredient:
Salicylic Acid 0.5%
Purpose:
Acne Treatment
Uses:
For the treatment of acne
Helps prevent new acne blemishes
Warning:
For external use only
When Using This Product:
Keep out of eyes, rinse with water to remove.
Skin irrittion and dryness is more likely to occur if you use another topical acne medications at the same time. If irritation occurs, only use one medication at a time.
Stop use and ask a doctor If
rash occurs
Keep Out of Reach of Children
Directions:
Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive Ingredient:
Water, Cyclopentasiloxane, Hydrogenated Polyisobutene, Ethoxydiglycol, Dimethicone, Cyclohexasiloxane, Dimethicone Crossploymer, PEG-10 Dimethicone, Dimethicone PEG 10/15 Crosspolymer, Magnesium Sulfate, Talc, Nylon-12, Phenoxyethanol, Propylene Glycol, Quaternium-18 Benonite, Triethoxycaprylysilane, Methylparaben, Ethylparaben, butylparaben, Propylparaben, Isobutylparaben, Cinnamomum Camphora (Camphor) Bark oil, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Jiuce, Hexapeptide-9, Hamamelis Birginiana (Witch Hazel)
May Contain:
Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76354-605-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4edc-f424-e053-dadaa90a57ce | Drug Fact |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76354-605-01 | ELF Caramel ACNE Fighting Foundation | 36 mL in 1 BOTTLE | CREAM | 36 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SALICYLIC ACID | ACTIVE INGREDIENT | O414PZ4LPZ | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| CAMPHOR OIL | INACTIVE INGREDIENT | 75IZZ8Y727 | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIMETHICONE PEG-10 PHOSPHATE | INACTIVE INGREDIENT | O7Q5NJ7X88 | 1 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| HYDROGENATED POLYBUTENE (1300 MW) | INACTIVE INGREDIENT | 7D1YQ9Y5EZ | 1 | |
| ISOBUTYLPARABEN | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| MAGNESIUM SULFATE | INACTIVE INGREDIENT | DE08037SAB | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| NYLON-12 | INACTIVE INGREDIENT | 446U8J075B | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TEA TREE OIL | INACTIVE INGREDIENT | VIF565UC2G | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| WITCH HAZEL | INACTIVE INGREDIENT | 101I4J0U34 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76354-605 | 76354-605-01 |
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 |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | DE08037SAB | TABLET, COATED / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| TALC | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 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 |
|---|---|---|---|---|---|---|
| 0ad1aee9-153f-4a85-9e00-1def26a6a72f | ee5ac24d-f709-48f7-b6ea-75934afc6274 | 2015-10-17 | Warnings | 0ad1aee9-153f-4a85-9e00-1def26a6a72f ee5ac24d-f709-48f7-b6ea-75934afc6274 |
Adverse event summaries are temporarily unavailable. Other product information remains available.