Drug Facts
Active ingredients Purpose
Titanium Dioxide 10.20% Sunscreen
Zinc Oxide 3.70% Sunscreen
Active ingredients Purpose
Titanium Dioxide 10.20% Sunscreen
Zinc Oxide 3.70% Sunscreen
USES
Helps protect against sunburn
Higher SPF gives more sunburn protection
Provides moderate protection against sunburn.
Warnings
For external use only. When using this product keep
out of eyes. Rinse with water to remove. Stop use and
ask doctor if rash and irritation develops and lasts.
Avoid contact with eyes. If product gets into eyes,
rinse thoroughly with water.
Keep out of reach of children. If swallowed, get
medical help or contact poison control center right
away.
Directions
Apply generously before sun exposure and as
needed. For children under 6 months, ask a doctor.
Reapply as needed or after towel drying, swimming
or perspiring.
Other Information
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other
harmful effects of the sun.
Inactive Ingredients
Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,
Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,
Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.
Keep out of reach of children. If swallowed get medical help or call Poison Control right away.
Apply generously before sun exposure and as
needed. For children under 6 months, ask a doctor.
Reapply as needed or after towel drying, swimming
or perspiring.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59958-202-20 | 2021-07-14 | C162847 | 48780-1 | ba0f9c33-3e64-a910-e053-dadaa90a0b85 | SFL Sunscreen - SOL Defense |
| 59958-202-20 | 2021-07-14 | C162847 | 48780-1 | ba0f9c33-3e64-a910-e053-dadaa90a0b85 | SFL Sunscreen - SOL Defense |
| 59958-202-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3e64-a910-e053-dadaa90a0b85 | SFL Sunscreen - SOL Defense |
| 59958-202-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3e64-a910-e053-dadaa90a0b85 | SFL Sunscreen - SOL Defense |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| Cyclomethicone | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| Tribehenin | INACTIVE INGREDIENT | 8OC9U7TQZ0 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59958-202 | 59958-202-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CYCLOMETHICONE | NMQ347994Z | IACT |
| TRIBEHENIN | 8OC9U7TQZ0 | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2025-01-10 | full-release | 2026-06-01 00:52:05 |
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 |
|---|---|---|---|---|---|---|
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| Cyclomethicone | CYCLOMETHICONE | NMQ347994Z | AEROSOL, FOAM / TOPICAL | 5.26 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| Cyclomethicone | CYCLOMETHICONE | NMQ347994Z | CREAM, AUGMENTED / TOPICAL | 7.6 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| Cyclomethicone | CYCLOMETHICONE | NMQ347994Z | CREAM / TOPICAL | 13 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| Cyclomethicone | CYCLOMETHICONE | NMQ347994Z | SOLUTION / TOPICAL | 11.57 %w/v | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| Cyclomethicone | CYCLOMETHICONE | NMQ347994Z | LOTION / TOPICAL | 3510 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 |
|---|---|---|---|---|---|---|
| 53e9324a-b935-18ee-e063-6394a90a027c | 4382d55d-1463-41e3-9805-4125055b2e42 | 2026-06-10 | Warnings | 53e9324a-b935-18ee-e063-6394a90a027c 4382d55d-1463-41e3-9805-4125055b2e42 |
Adverse event summaries are temporarily unavailable. Other product information remains available.