OTC - ACTIVE INGREDIENT SECTION
Active Ingredient : Titanium Dioxide 9 %
Active Ingredient : Titanium Dioxide 9 %
Purpose : Sunscreen
Discontinue use If rash or irritation develops and increases. If irritation persists, consult a health care practitioner or Contact a Poison Control Center right away.
Keep Out of Reach of Children .
Inactive Ingredients : Mica , Boron Nitride , Caprylic/Capric Triglyceride , Bismuth Oxychloride , Zinc Stearate , Magnesium Silicate , Magnesium Carbonate ,Sodium Starch Octenylsuccinate, Mannitol,
Sodium Gluconate , Citric Acid, Sodium Citrate , Walthena Indica Leaf Extract , Dextrin , Ferulic Acid, L-Lactic Acid, Butyrospermum Parkii (Shea Butter) , Silica, Thioctic Acid,Sodium Hyarluronate, Retinol,
L-Ascorbic Acid, Ceramide 6 II , Magnolia Officinalis Bark Extract, Vitis Vinifera (Grape) Seed Extract , Tocopherol , Lecithin , Maltodextrin , Vitis Vinifera (Grape) Fruit Skin, Glycerin, Palmitoyl Tripeptide-5,
L-Glucothione, Aloe Barbadensis Leaf Extract, Hydrated Silica , Tocopheryl Acetate , Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambus Vulgaris Leaf/Stem Extract, Magnesium Carbonate ,
Iron oxide , May contain : Titanium Dioxide, Ultramarines.
For external use only. Please avoid contact inside eyes. Rinse with water to remove.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a21a21e5-f36d-4c1f-8918-def921b8f7e3 | Product name | 3 | 20250124 |
| 910c1bd7-67d1-44c7-ad4f-9445f827edcc | Product name | 1 | 20230808 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67345-0788-0 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-ceff-8e05-e053-dbdaa90a074a | 9eabd702-68e2-40bb-b227-e85cb2b894e3 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67345-0788-0 | 4 in 1 Pressed Mineral SPF 15 Deep | 8 g in 1 CASE | POWDER | 8 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67345-0788 | 4 IN 1 PRESSED MINERAL SPF 15 DEEP (TITANIUM DIOXIDE) POWDER [PUR MINERALS] | 1 | Legacy NDC, 1 package rows | 20110916_9eabd702-68e2-40bb-b227-e85cb2b894e3.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Acetate Ion | INACTIVE INGREDIENT | 569DQM74SC | 1 | |
| Bismuth Oxychloride | INACTIVE INGREDIENT | 4ZR792I587 | 1 | |
| Boron Nitride | INACTIVE INGREDIENT | 2U4T60A6YD | 1 | |
| Iron | INACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| MAGNESIUM CARBONATE | INACTIVE INGREDIENT | 0E53J927NA | 1 | |
| Magnesium Silicate | INACTIVE INGREDIENT | 9B9691B2N9 | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| Mica | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| Shea Butter | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Zinc Stearate | INACTIVE INGREDIENT | H92E6QA4FV | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67345-0788 | 67345-0788-0 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Mica | V8A1AW0880 | IACT |
| Titanium Dioxide | 15FIX9V2JP | ACTIB |
| Boron Nitride | 2U4T60A6YD | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| Bismuth Oxychloride | 4ZR792I587 | IACT |
| Zinc Stearate | H92E6QA4FV | IACT |
| Magnesium Silicate | 9B9691B2N9 | IACT |
| MAGNESIUM CARBONATE | 0E53J927NA | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| Shea Butter | K49155WL9Y | IACT |
| Acetate Ion | 569DQM74SC | IACT |
| Iron | E1UOL152H7 | IACT |
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 |
|---|---|---|---|---|---|---|
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | TABLET / SUBLINGUAL | 2.5 mg | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | TABLET, FILM COATED / ORAL | 500 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | LOTION / TOPICAL | 7 %w/w | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, DELAYED RELEASE / ORAL | 180 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 990.3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | CAPSULE, EXTENDED RELEASE / ORAL | 180 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | SOAP / TOPICAL | 0.33 %w/w | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | CAPSULE / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | CAPSULE, DELAYED RELEASE / ORAL | 180 mg | ||
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | TABLET, EXTENDED RELEASE / ORAL | 36 mg | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | TABLET, COATED / ORAL | 28.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CREAM / TOPICAL | 3300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | CAPSULE, COATED PELLETS / ORAL | 22.4 mg | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET / SUBLINGUAL | 1.2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SUSPENSION / ORAL | 10170 mg | ||
| Shea Butter | SHEA BUTTER | K49155WL9Y | LOTION / TOPICAL | 2340 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | CAPSULE / ORAL | 22.4 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SPRAY, METERED / SUBLINGUAL | 110 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| MAGNESIUM CARBONATE | MAGNESIUM CARBONATE | 0E53J927NA | TABLET, DELAYED RELEASE / ORAL | 250 mg | ||
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | TABLET / ORAL | 72 mg | ||
| Zinc Stearate | ZINC STEARATE | H92E6QA4FV | SHAMPOO / TOPICAL | 2 %w/w | ||
| Magnesium Silicate | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, COATED / ORAL | 29.03 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 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 |
|---|---|---|---|---|---|---|
| c34d07c4-6993-42a3-85be-34576165d619 | 9eabd702-68e2-40bb-b227-e85cb2b894e3 | 2011-09-15 | Warnings | c34d07c4-6993-42a3-85be-34576165d619 9eabd702-68e2-40bb-b227-e85cb2b894e3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.