OTC - ACTIVE INGREDIENT SECTION
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3
PURPOSE: SUNSCREEN
OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL PALMITATE, ISOPROPYL ISOSTEARATE, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, SILICA, DI-PPG-3 MYRISTYL ETHER ADIPATE, GLYCERYL STEARATE, STEARIC ACID, SACCHARIDE ISOMERATE, POLYSORBATE 20, LECITHIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, POLYSILICONE-11, LAURETH-12, CYCLOPENTASILOXANE, ACRYLATES/DIMETHICONE COPOLYMER, METHYLSILANOL MANNURONATE, DMDM HYDANTOIN, TRIHYDROXYSTEARIN, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TETRASODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, BORAGO OFFICINALIS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ALGAE EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891] [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]
MOISTURIZING MAKEUP WITH SPF 15
TO USE: SMOOTH ON WITH FINGERS OR SPONGE.
DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.
KEEP OUT OF REACH OF CHILDREN.
CLINICALLY, ALLERGY AND IRRITANCY TESTED.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68828-048-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-58d5-f424-e053-dadaa90a57ce | MOISTURIZING MAKEUP SPF-15 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68828-048-11 | MOISTURIZING MAKEUPSPF 15 | 1 in 1 BOX | LOTION | 1 | 1 | |
| 68828-048-67 | MOISTURIZING MAKEUPSPF 15 | 30 mL in 1 BOTTLE | LOTION | 30 | 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 | |
| BORAGE | INACTIVE INGREDIENT | PB618V0K2W | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CALENDULA OFFICINALIS FLOWER | INACTIVE INGREDIENT | P0M7O4Y7YD | 1 | |
| CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) | INACTIVE INGREDIENT | 59TL3WG5CO | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DI-PPG-3 MYRISTYL ETHER ADIPATE | INACTIVE INGREDIENT | T32481VTXW | 1 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 1 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| HYDROGENATED PALM GLYCERIDES | INACTIVE INGREDIENT | YCZ8EM144Q | 1 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 1 | |
| IPOMOEA MAURITIANA TUBER | INACTIVE INGREDIENT | K67Y2SGX79 | 1 | |
| ISOPROPYL ISOSTEARATE | INACTIVE INGREDIENT | C67IXB9Y7T | 1 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 1 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| LAURETH-12 | INACTIVE INGREDIENT | OAH19558U1 | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| MACROCYSTIS PYRIFERA | INACTIVE INGREDIENT | K31S3OG5C4 | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| METHYLSILANOL ACETYLMETHIONATE | INACTIVE INGREDIENT | FKT0KP5RFC | 1 | |
| MUNG BEAN | INACTIVE INGREDIENT | 1LIB31N73G | 1 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 1 | |
| PEG-4 LAURATE | INACTIVE INGREDIENT | AYF4VM3N1Z | 1 | |
| POLYSILICONE-15 | INACTIVE INGREDIENT | F8DRP5BB29 | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| POTASSIUM CETYL PHOSPHATE | INACTIVE INGREDIENT | 03KCY6P7UT | 1 | |
| SACCHARIDE ISOMERATE | INACTIVE INGREDIENT | W8K377W98I | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIHYDROXYSTEARIN | INACTIVE INGREDIENT | 06YD7896S3 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| WITHANIA SOMNIFERA FLOWER | INACTIVE INGREDIENT | 2HZ95R7082 | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68828-048 | 68828-048-67, 68828-048-11 |
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 |
|---|---|---|---|---|---|---|
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | CAPSULE / ORAL | 563 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET, CHEWABLE / ORAL | 12 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 23 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | AEROSOL, SPRAY / TOPICAL | 397 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | INJECTION / INTRAVENOUS | 0.01 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAVENOUS | 30 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | EMULSION / OPHTHALMIC | 0.02 %w/v | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION/ DROPS / ORAL | 4.15 mg/2.5ml | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | CAPSULE / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, DELAYED RELEASE / ORAL | 15 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| TRIHYDROXYSTEARIN | TRIHYDROXYSTEARIN | 06YD7896S3 | CREAM / TOPICAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | OINTMENT / VAGINAL | 231 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | POWDER, FOR SUSPENSION / ORAL | 1.3 mg/5ml | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 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 |
|---|---|---|---|---|---|---|
| c0aa639c-80e2-4ee9-bdff-20156248716a | b7777bf9-cefb-4d24-b8ca-d4352f22c0ca | 2012-05-01 | Warnings | c0aa639c-80e2-4ee9-bdff-20156248716a b7777bf9-cefb-4d24-b8ca-d4352f22c0ca |
Adverse event summaries are temporarily unavailable. Other product information remains available.