Storage and handling
Other Information PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Other Information PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Active Ingredient:
OCTINOXATE: 7.5%
OCTISALATE: 5%
OXYBENZONE: 3%
Purpose:
Sunscreen
Uses:
Help prevent sunburn
Warning:
For external use only
Skin Cancer/Skin Aging Alert:
DO NOT USE ON DAMAGED OR BROKEN SKIN.
When Using This Product
Stop use and ask a doctor if
KEEP OUT OF REACH OF CHILDREN.
Directions:
SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SUN CANCER AND EARLY AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION INCLUDING:
Other Information
Inactive Ingredient:
WATER (AQUA), PARAFFINUM LIQUIDUM (MINERAL OIL), PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STEARETH-21, DIMETHICONE, STEARETH-2, CETEARYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, XANTHAN GUM, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, RETINYL PALMITATE (VA), TOCOPHERYL ACETATE (VE), MAGNESIUM ASCORBYL PHOSPHATE (VC), ALOE VERA LEAF JUICE, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT
May Contain: TITANIUM DIOXIDE (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)
QUESTIONS OR COMMENTS
1-855-353-7320
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76354-112-51 | 2019-12-26 | C162847 | 48780-1 | 9855e2a2-4a88-60a7-e053-dbdaa90a05bd | f793c4c5-2270-483b-818d-c16b7ebfe836 |
| 76354-112-51 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a88-60a7-e053-dbdaa90a05bd | f793c4c5-2270-483b-818d-c16b7ebfe836 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| C12-15 ALKYL BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 2 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 2 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 2 | |
| CUCUMBER | INACTIVE INGREDIENT | YY7C30VXJT | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 2 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 2 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 2 | |
| MAGNESIUM ASCORBYL PHOSPHATE | INACTIVE INGREDIENT | 0R822556M5 | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 2 | |
| POLYACRYLAMIDE (10000 MW) | INACTIVE INGREDIENT | E2KR9C9V2I | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | 2 | |
| STEARETH-21 | INACTIVE INGREDIENT | 53J3F32P58 | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76354-112 | 76354-112-11, 76354-112-51 |
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 |
|---|---|---|---|---|---|---|
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 23 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| STEARETH-21 | STEARETH-21 | 53J3F32P58 | LOTION / TOPICAL | 3 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / TOPICAL | 552 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 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 |
|---|---|---|---|---|---|---|
| 0ee81f49-f2da-44ba-8b94-6ae249d5bd2e | f793c4c5-2270-483b-818d-c16b7ebfe836 | 2014-08-28 | Warnings | f793c4c5-2270-483b-818d-c16b7ebfe836 |
Adverse event summaries are temporarily unavailable. Other product information remains available.