OTC - ACTIVE INGREDIENT SECTION
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3
PURPOSE: SUNSCREEN
OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL ISOSTEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, STEARIC ACID, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE, LECITHIN, POLYETHYLENE, METHYL METHACRYLATE COPOLYMER, SILICA, DIMETHICONE, SODIUM HYALURONATE, TREHALOSE, SODIUM PCA, POLYQUATERNIUM-51, UREA, GLYCERIN, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYSORBATE 20, TRIETHANOLAMINE, TAGETUS ERECTA (AFRICAN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, PROPYLENE GLYCOL, MACROCYSTIS PYRIFERA EXTRACT, HYDROLYZED WHEAT PROTEIN, PVP, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, FRAGRANCE/PARFUM, PANTHENOL, TOCOPHERYL ACETATE, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA [MAY CONTAIN, +/-: TITANIUM DIOXIDE/CI 77891, IRON OXIDES/CI 77491/CI 77492/CI 77499] [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, ALPHA-ISOMETHYL IONONE, GERANIOL, LIMONENE, LINALOOL].
SPF 15 PROTECTS AGAINST DAMAGING ULTRAVIOLET RAYS. MATTE FINISH. SHEER TO MEDIUM COVERAGE.
TO USE: SMOOTH ON WITH FINGERS OR SPONGE.
CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.
DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.
KEEP OUT OF REACH OF CHILDREN.
JAFRA
TESTER SKIN DEFENSE MAKEUP SPF 15
CONTAINS: 10 TESTERS AT .27 FL OZ EACH
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68828-047-67 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6b32-f424-e053-dadaa90a57ce | SKIN DEFENSE MAKEUP SPF-15 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68828-047-11 | SKIN DEFENSE MAKEUPSPF 15 | 30 mL in 1 BOTTLE | LOTION | 30 | 1 | |
| 68828-047-67 | SKIN DEFENSE MAKEUPSPF 15 | 1 in 1 BOX | LOTION | 1 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| BIOSACCHARIDE GUM-1 | INACTIVE INGREDIENT | BB4PU4V09H | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CHONDRUS CRISPUS | INACTIVE INGREDIENT | OQS23HUA1X | 1 | |
| DI-PPG-3 MYRISTYL ETHER ADIPATE | INACTIVE INGREDIENT | T32481VTXW | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 1 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| HYDROGENATED PALM GLYCERIDES | INACTIVE INGREDIENT | YCZ8EM144Q | 1 | |
| HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) | INACTIVE INGREDIENT | J2S07SB0YL | 1 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 1 | |
| IPOMOEA MAURITIANA TUBER | INACTIVE INGREDIENT | K67Y2SGX79 | 1 | |
| ISOPROPYL ISOSTEARATE | INACTIVE INGREDIENT | C67IXB9Y7T | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| MACROCYSTIS PYRIFERA | INACTIVE INGREDIENT | K31S3OG5C4 | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| METHYL METHACRYLATE | INACTIVE INGREDIENT | 196OC77688 | 1 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 1 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 1 | |
| PEG-4 LAURATE | INACTIVE INGREDIENT | AYF4VM3N1Z | 1 | |
| POLIDRONIUM CHLORIDE | INACTIVE INGREDIENT | 6716Z5YR3G | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| POTASSIUM CETYL PHOSPHATE | INACTIVE INGREDIENT | 03KCY6P7UT | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM PYRROLIDONE CARBOXYLATE | INACTIVE INGREDIENT | 469OTG57A2 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TAGETES ERECTA FLOWER | INACTIVE INGREDIENT | UH5X33P33E | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TREHALOSE | INACTIVE INGREDIENT | B8WCK70T7I | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| UREA | INACTIVE INGREDIENT | 8W8T17847W | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68828-047 | 68828-047-11, 68828-047-67 |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, EXTENDED RELEASE / ORAL | 4.2 mg | ||
| CHONDRUS CRISPUS | CHONDRUS CRISPUS | OQS23HUA1X | LOTION / TOPICAL | NA | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE PARTICLES / ORAL | 70 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SHAMPOO / TOPICAL | 1.25 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION, EXTENDED RELEASE / ORAL | 474 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 857 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / INTRAVENOUS | 30 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CLOTH / TOPICAL | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CAPSULE, EXTENDED RELEASE / ORAL | 4.53 mg | ||
| UREA | UREA | 8W8T17847W | SYSTEM / TOPICAL | 1260 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | EMULSION / TOPICAL | 0.5 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SYSTEM / TRANSDERMAL | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CREAM / TOPICAL | 900 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET / ORAL | 17 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | OINTMENT / TOPICAL | 94 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAMUSCULAR | 1.62 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| HYALURONATE SODIUM | SODIUM HYALURONATE | YSE9PPT4TH | GEL / TOPICAL | 463 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | EMULSION / TOPICAL | 2 %w/w | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | FILM, EXTENDED RELEASE / TRANSDERMAL | 85 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAVENOUS | 30 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | 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 |
|---|---|---|---|---|---|---|
| 18abcbd7-0299-4c20-9fd7-317a988b891d | c57bce22-619e-43ab-875a-99821f82111f | 2012-04-27 | Warnings | 18abcbd7-0299-4c20-9fd7-317a988b891d c57bce22-619e-43ab-875a-99821f82111f |
Adverse event summaries are temporarily unavailable. Other product information remains available.