OTC - ACTIVE INGREDIENT SECTION
Octinoxate......7.5%
Octisalate.......5.0%
Oxybenzone...... 5.0%
Titanium Dioxide......1.2%
Octinoxate......7.5%
Octisalate.......5.0%
Oxybenzone...... 5.0%
Titanium Dioxide......1.2%
water (aqua), c12-15 alkyl benzoate, cyclopentasiloxane, glycerin, steareth-21, dimethicone, methyl methacrylate/glycol dimethacrylate crosspolymer, behenyl alcohol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dimethicone crosspolymer, steareth-2, retinyl palmitate, phytosterols, tocotrienols, tocopherol, squalene, oryza sative (rice) bran wax, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, rubus fruticosus (blackberry) leaf extract, melanin, lavandula angustifolia (lavender) oil, aloe barbadensis leaf juice, maltodextrin, carbomer, butylene glycol, polysorbate 20, simethicone, alumina, sorbitan laurate, quercetin, diethylhexyl syringylidene malonate, capric caprylic triglycerides, disodium edta, chlorphenesin, phenoxyethanol.
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
HELPS PREVENT SUNBURN. HIGHER SPF GIVES MORE SUNBURN PROTECTION
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50184-4800-2 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb7d-621f-e053-dbdaa90a74ad | Active Ingredients |
| 50184-4800-4 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb7d-621f-e053-dbdaa90a74ad | Active Ingredients |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50184-4800-1 | Shelter | 56.7 g in 1 TUBE | CREAM | 56.7 | 1 | |
| 50184-4800-2 | Shelter | 1 in 1 BOX | CREAM | 1 | 1 | |
| 50184-4800-3 | Shelter | 113.4 g in 1 TUBE | CREAM | 113.4 | 1 | |
| 50184-4800-4 | Shelter | 1 in 1 BOX | CREAM | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50184-4800 | SHELTER (OCTINOXATE AND OCTISALATE AND OXYBENZONE AND TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.] | 1 | Legacy NDC, 4 package rows | 20100301_b9acfee5-5956-41c1-8ef8-45f04890b28d.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 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| Titanium | ACTIVE MOIETY | D1JT611TNE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50184-4800 | 50184-4800-1, 50184-4800-2, 50184-4800-3, 50184-4800-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Octinoxate | 4Y5P7MUD51 | ACTIB |
| Octisalate | 4X49Y0596W | ACTIB |
| Oxybenzone | 95OOS7VE0Y | ACTIB |
| Titanium Dioxide | 15FIX9V2JP | ACTIB |
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 |
|---|---|---|---|---|---|---|
| d57415b0-ed15-4226-9d41-184f96e1ca91 | b9acfee5-5956-41c1-8ef8-45f04890b28d | 2010-02-23 | d57415b0-ed15-4226-9d41-184f96e1ca91 b9acfee5-5956-41c1-8ef8-45f04890b28d |
Adverse event summaries are temporarily unavailable. Other product information remains available.