OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Titanium Dioxide 6.2%
Zinc Oxide 4.2%
Purpose: Sunscreen
Active Ingredients:
Titanium Dioxide 6.2%
Zinc Oxide 4.2%
Purpose: Sunscreen
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 31645-142-02 | 2020-01-30 | C162847 | 48780-1 | 9855d018-e738-cd31-e053-dbdaa90ab51a | DRUG FACTS |
| 31645-142-02 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e738-cd31-e053-dbdaa90ab51a | DRUG FACTS |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 2 | |
| DEHYDROACETIC ACID | INACTIVE INGREDIENT | 2KAG279R6R | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 2 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 31645-142 | 31645-142-01, 31645-142-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| SQUALANE | GW89575KF9 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| VITAMIN A PALMITATE | 1D1K0N0VVC | IACT |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | IACT |
| DEHYDROACETIC ACID | 2KAG279R6R | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | 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 |
|---|---|---|---|---|---|---|
| KAOLIN | KAOLIN | 24H4NWX5CO | CAPSULE, EXTENDED RELEASE / ORAL | 21 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | SOLUTION / TOPICAL | 1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | CREAM, AUGMENTED / TOPICAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | CAPSULE / ORAL | NA | ||
| DEHYDROACETIC ACID | DEHYDROACETIC ACID | 2KAG279R6R | SHAMPOO / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | POWDER / TOPICAL | 10056 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | CAPSULE, COATED PELLETS / ORAL | 234 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| .ALPHA.-TOCOPHEROL ACETATE, DL- | .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | AEROSOL, FOAM / TOPICAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | SYRUP / ORAL | 10 mg/1ml | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | TABLET, EXTENDED RELEASE / ORAL | 66 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 |
|---|---|---|---|---|---|---|
| 47ad31b1-0409-43aa-89c0-b4b87faf46fa | 597c8c5b-c413-4299-a976-dfd612b43f4d | 2012-12-10 | 47ad31b1-0409-43aa-89c0-b4b87faf46fa 597c8c5b-c413-4299-a976-dfd612b43f4d |
Adverse event summaries are temporarily unavailable. Other product information remains available.