OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: OCTINOXATE 7.40% [] OCTISALATE 4.00% [] ZINC OXIDE 3.50% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%
ACTIVE INGREDIENTS: OCTINOXATE 7.40% [] OCTISALATE 4.00% [] ZINC OXIDE 3.50% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%
INACTIVE INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] OCTYLDODECYL NEOPENTANOATE [] TOCOPHERYL ACETATE [] CAFFEINE [] GLYCYRRHETINIC ACID [] UREA [] SODIUM HYALURONATE [] SQUALANE [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] GLYCERIN [] LECITHIN [] POLYGLYCERYL-6 POLYRICINOLEATE [] CHOLESTEROL [] TREHALOSE [] SODIUM PCA [] ORYZANOL [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SUCROSE [] SODIUM STEAROYL LACTYLATE [] XANTHAN GUM [] POLYQUATERNIUM-51 [] ISOPROPYL TITANIUM TRIISOSTEARATE [] TRIETHOXYCAPRYLYLSILANE [] SILICA [] ALUMINA [] LINOLEIC ACID [] STEARIC ACID [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DISODIUM EDTA [] PHENOXYETHANOL [] CHLORPHENESIN [] SODIUM DEHYDROACETATE [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] FERRIC FERROCYANIDE (CI 77510) [] YELLOW 5 LAKE (CI 19140)]
DIRECTIONS: SMOOTH EVENLY ALL OVER THE FACE OR TO THE DESIRED AREAS AFTER MOISTURIZER WITH FINGERTIPS, SPONGE OR BRUSH.
WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, DISCONTINUE USE AND CONTACT A HEALTH CARE PRACTITIONER.
KEEP OUT OF REACH OF CHILDREN.
PRINCIPAL DISPLAY PANEL:
MACPREP + PRIME
FORTIFIED SKIN ENHANCER
SPF 35
NT WT 1.0 FL OZ/ 30 ML
DISTR BY MAKE UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 2dc76302-91c0-4c35-ad78-99adfb049c4b | Product name | 1 | 20200603 |
| e6065d4b-5ae1-476f-a40e-f2851cbb5d2b | Product name | 2 | 20180221 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 56625fcc-aa34-9d30-d0e9-1c1beb37ea21 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| d223c173-c39b-d764-47d4-d671d3088815 | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0039-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0550-f424-e053-dadaa90a57ce | a1b22e6f-5dde-48b0-86f2-305b1bc67c0c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0039-1 | PREP AND PRIMEFORTIFIED SKIN ENHANCER SPF 35 | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 40046-0039-2 | PREP AND PRIMEFORTIFIED SKIN ENHANCER SPF 35 | 30 mL in 1 TUBE | CREAM | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0039 | PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20110715_a1b22e6f-5dde-48b0-86f2-305b1bc67c0c.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| BARLEY | INACTIVE INGREDIENT | 5PWM7YLI7R | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CAFFEINE | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DOCOSANOL | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ENOXOLONE | INACTIVE INGREDIENT | P540XA09DR | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| GAMMA ORYZANOL | INACTIVE INGREDIENT | SST9XCL51M | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| LINOLEIC ACID | INACTIVE INGREDIENT | 9KJL21T0QJ | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| OCTYLDODECYL NEOPENTANOATE | INACTIVE INGREDIENT | X8725R883T | 1 | |
| OCTYLDODECYL STEAROYL STEARATE | INACTIVE INGREDIENT | 3D47Q6D93C | 1 | |
| PEG-40 STEARATE | INACTIVE INGREDIENT | ECU18C66Q7 | 1 | |
| PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) | INACTIVE INGREDIENT | 255PIF62MS | 1 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| POLYMETHYLSILSESQUIOXANE (11 MICRONS) | INACTIVE INGREDIENT | Z570VEV8XK | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM DEHYDROACETATE | INACTIVE INGREDIENT | 8W46YN971G | 1 | |
| SODIUM PYRROLIDONE CARBOXYLATE | INACTIVE INGREDIENT | 469OTG57A2 | 1 | |
| SODIUM STEAROYL LACTYLATE | INACTIVE INGREDIENT | IN99IT31LN | 1 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| TREHALOSE | INACTIVE INGREDIENT | B8WCK70T7I | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| UREA | INACTIVE INGREDIENT | 8W8T17847W | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| WHEAT GERM | INACTIVE INGREDIENT | YR3G369F5A | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 40046-0039 | 40046-0039-2, 40046-0039-1 |
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 |
|---|---|---|---|---|---|---|
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| CAFFEINE | CAFFEINE | 3G6A5W338E | SOLUTION / OPHTHALMIC | 2 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / OPHTHALMIC | 0.06 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAMUSCULAR | 10 %w/v | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| HYALURONATE SODIUM | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRAVITREAL | 23 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v |
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 |
|---|---|---|---|---|---|---|
| 8e82c4a4-fbc9-46bb-980e-31e302be7f7a | a1b22e6f-5dde-48b0-86f2-305b1bc67c0c | 2011-07-14 | Warnings | 8e82c4a4-fbc9-46bb-980e-31e302be7f7a a1b22e6f-5dde-48b0-86f2-305b1bc67c0c |
Adverse event summaries are temporarily unavailable. Other product information remains available.