Directions • Apply generously to face 15 minutes before sun exposure. • Children under 6 months of age: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures. • limit time in the sun, especially from 10 a.m.-2 p.m. • we...
Titanium Dioxide 6.90%
Sunscreen
Helps prevent sunburn
Warning
• For external use only.
• Do not use on damaged or broken skin
When using this product
• Keep out of eyes. Rinse with water to remove.
Stop use and ask 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.
Directions
• Apply generously to face 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
Sun Protection Measures:
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures.
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating; immediately after towel drying
Cyclopentasiloxane, Isododecane, Glyceryl Behenate, PEG-10 Dimethicone, Polysilicone-11, Alumina, Water, Methicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Prunus Persica (Peach) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Root Extract, Jasminum Officinale (Jasmine) Extract, Amaranthus Caudatus Seed Extract, Ethylhexylglycerin, Phenoxyethanol.
Other Information
• protect the product in this container from excessive heat and direct sun
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69863-101-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fb12-f424-e053-dadaa90a57ce | ec3bea36-644d-4263-970c-5e001a257fc7 |
| 69863-101-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fb12-f424-e053-dadaa90a57ce | ec3bea36-644d-4263-970c-5e001a257fc7 |
| 69863-101-51 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fb12-f424-e053-dadaa90a57ce | ec3bea36-644d-4263-970c-5e001a257fc7 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69863-101-11 | SMOOTHING MINERAL PRIMERSPF-15 | 30 mL in 1 BOTTLE, PUMP | LOTION | 30 | 4 | |
| 69863-101-12 | SMOOTHING MINERAL PRIMERSPF-15 | 5 mL in 1 TUBE | LOTION | 5 | 4 | |
| 69863-101-13 | SMOOTHING MINERAL PRIMERSPF-15 | 7 mL in 1 TUBE | LOTION | 7 | 4 | |
| 69863-101-51 | SMOOTHING MINERAL PRIMERSPF-15 | 1 in 1 BOX | LOTION | 1 | 4 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 2 | |
| AMARANTHUS CAUDATUS SEED | INACTIVE INGREDIENT | FJ722PPQ9M | 2 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 2 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 2 | |
| GLYCERYL MONOBEHENATE | INACTIVE INGREDIENT | A626UU0W2A | 2 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 2 | |
| JASMINUM OFFICINALE FLOWER | INACTIVE INGREDIENT | 0Q8K841432 | 2 | |
| LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE | INACTIVE INGREDIENT | 25G622K2RA | 2 | |
| METHICONE (20 CST) | INACTIVE INGREDIENT | 6777U11MKT | 2 | |
| OENOTHERA BIENNIS ROOT | INACTIVE INGREDIENT | SL194W0S0F | 2 | |
| PEACH | INACTIVE INGREDIENT | 3OKE88I3QG | 2 | |
| PEG-10 DIMETHICONE (600 CST) | INACTIVE INGREDIENT | 8PR7V1SVM0 | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYSILICONE-15 | INACTIVE INGREDIENT | F8DRP5BB29 | 2 | |
| VITIS VINIFERA SEED | INACTIVE INGREDIENT | C34U15ICXA | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69863-101 | 69863-101-11, 69863-101-51, 69863-101-12, 69863-101-13 |
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 |
|---|---|---|---|---|---|---|
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w |
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 |
|---|---|---|---|---|---|---|
| 99f8dd9f-b9d2-4169-abe8-71850527fab1 | ec3bea36-644d-4263-970c-5e001a257fc7 | 2015-12-16 | Warnings | 99f8dd9f-b9d2-4169-abe8-71850527fab1 ec3bea36-644d-4263-970c-5e001a257fc7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.