OTC - ACTIVE INGREDIENT SECTION
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OXYBENZONE/BENZOPHENONE-3, OCTISALATE/ETHYLHEXYL SALICYLATE, OCTOCRYLENE, TITANIUM DIOXIDE/CI 77891.
PURPOSE: SUNSCREEN
OTHER INGREDIENTS: WATER/AQUA, C12-15 ALKYL BENZOATE, ALUMINA, DIMETHICONE, ETHYLHEXYL ETHYLHEXANOATE, SODIUM DIHYDROXYCETYL PHOSPHATE, BUTYLENE GLYCOL, GLYCERYL STEARATE SE, ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER, PANTHENOL, TOCOPHERYL ACETATE, AVENA SATIVA (OAT) KERNEL EXTRACT, PVP/EICOSENE COPOLYMER, CETYL ALCOHOL, XANTHAN GUM, BEESWAX/CERA ALBA, FRAGRANCE/PARFUM, IRON OXIDES/CI 77491/CI 77492/CI 77499, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, DMDM HYDANTOIN, TRISODIUM EDTA.
FACE PROTECTOR SPF 40
TO USE: APPLY SUNSCREEN PRODUCT 20 MINUTES BEFORE EXPOSURE. RE-APPLY FREQUENTLY TO MAINTAIN PROTECTION, ESPECIALLY AFTER PERSPIRING, SWIMMING OR TOWELING.
DISCONTINUE USE IF IRRITATION OCCURS.
KEEP OUT OF REACH OF CHILDREN.
CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68828-054-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-58f9-f424-e053-dadaa90a57ce | FACE PROTECTOR SPF 40 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68828-054-13 | FACE PROTECTORSPF 40 | 50 mL in 1 TUBE | LOTION | 50 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68828-054 | FACE PROTECTOR SPF 40 (OCTINOXATE OXYBENZONE OCTISALATE OCTOCRYLENE TITANIUM DIOXIDE) LOTION [JAFRA COSMETICS INTERNATIONAL] | 3 | Legacy NDC, 1 package rows | 20120515_56b5e11c-bf43-414e-ae17-4cebc47ae27b.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 3 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 3 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 3 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 3 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 3 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 3 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 3 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 3 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 3 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 3 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 3 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 3 | |
| DIETHYLENE GLYCOL ADIPATE | INACTIVE INGREDIENT | 6KE5V549E0 | 3 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 3 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 3 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 3 | |
| ETHYLHEXYL ETHYLHEXANOATE | INACTIVE INGREDIENT | 430RJA6715 | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 3 | |
| GLYCERYL STEARATE SE | INACTIVE INGREDIENT | FCZ5MH785I | 3 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 3 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 3 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 3 | |
| PEG-4 LAURATE | INACTIVE INGREDIENT | AYF4VM3N1Z | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 3 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68828-054 | 68828-054-13 |
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 |
|---|---|---|---|---|---|---|
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 45 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION/ DROPS / OPHTHALMIC | 4 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | FILM / SUBLINGUAL | 7 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| DMDM HYDANTOIN | DMDM HYDANTOIN | BYR0546TOW | LOTION / TOPICAL | 3 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| EDETATE TRISODIUM | EDETATE TRISODIUM | 420IP921MB | CREAM / TOPICAL | NA | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| SODIUM PHOSPHATE, MONOBASIC | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.07 %w/v | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / SUBLINGUAL | 30 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FOR SUSPENSION / ORAL | 462 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, EXTENDED RELEASE / ORAL | 368 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SOLUTION / ORAL | 2832 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE PARTICLES / ORAL | 70 mg | ||
| SODIUM PHOSPHATE, MONOBASIC | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION / INTRAMUSCULAR | 161 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / OPHTHALMIC | 14 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED / ORAL | 245 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER / ORAL | 378 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | PELLET / ORAL | 24 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | FILM, EXTENDED RELEASE / TRANSDERMAL | 16 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 |
|---|---|---|---|---|---|---|
| 0f9997cc-6ace-4e05-aaa1-c6d659ebb79d | 56b5e11c-bf43-414e-ae17-4cebc47ae27b | 2012-05-14 | Warnings | 0f9997cc-6ace-4e05-aaa1-c6d659ebb79d 56b5e11c-bf43-414e-ae17-4cebc47ae27b |
Adverse event summaries are temporarily unavailable. Other product information remains available.