Dosage and administration
Apply evenly before sun exposure as needed. Children under 6 months of age: ask a doctor.
Apply evenly before sun exposure as needed. Children under 6 months of age: ask a doctor.
Octinoxate 7%
Oxybenzone 3%
Titanium Dioxide 5%
Sunscreen
For external use only.
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Silica, Cetyl Dimethicone, Beeswax, Octyldodecyl Neopentanoate, Euphorbia Cerifera (Candelilla) Wax, Propylene Glycol Laurate, Polyethylene, Nylon-12, VP/Hexadecene Copolymer,Octyldodecanol, Ethylhexylglycerin, Cetyl Palmitate, Tocopherol, Tocopheryl Acetate, Ascorbyl Palmitate, Cantella Asiatica Extract, Camellia Sinensis Leaf Extract, Sorbitan Sesquioleate, Water, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol. May Contain: Mica, Titanium Dioxide, Iron Oxides.
Call Laura Geller Make-up, Inc., 1(800) MAKE UP4
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51389-111-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e7a1-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51389-111-11 | Real Deal FoundationMEDIUM DEEP | 1 in 1 KIT | STICK | 1 | 1 | |
| 51389-111-11 | Real Deal FoundationMEDIUM DEEP | 14.20 g in 1 CYLINDER | STICK | 14.20 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| CENTELLA ASIATICA | INACTIVE INGREDIENT | 7M867G6T1U | 1 | |
| CETYL PALMITATE | INACTIVE INGREDIENT | 5ZA2S6B08X | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| HEXYLENE GLYCOL | INACTIVE INGREDIENT | KEH0A3F75J | 1 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 1 | |
| OCTYLDODECYL NEOPENTANOATE | INACTIVE INGREDIENT | X8725R883T | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PROPYLENE GLYCOL LAURATES | INACTIVE INGREDIENT | 40KT317HGP | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51389-111 | 51389-111-11 |
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 |
|---|---|---|---|---|---|---|
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | GEL / TOPICAL | 26 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | LOTION / TOPICAL | 7 %w/w | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| CETYL PALMITATE | CETYL PALMITATE | 5ZA2S6B08X | CREAM / VAGINAL | 165 mg | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | SYSTEM / TRANSDERMAL | 4.05 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | OINTMENT / OPHTHALMIC | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | PASTE / TOPICAL | 2.5 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TAPE / TOPICAL | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, COATED / ORAL | 25 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET / ORAL | 50 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| HEXYLENE GLYCOL | HEXYLENE GLYCOL | KEH0A3F75J | SOLUTION / TOPICAL | 0.3 %w/w | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | FILM, EXTENDED RELEASE / TRANSDERMAL | 253.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | JELLY / VAGINAL | 42.6 %w/w | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | TABLET / ORAL | 7.14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CAPSULE, EXTENDED RELEASE / ORAL | 4.53 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SUPPOSITORY / VAGINAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CREAM / TOPICAL | 54.5 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | OINTMENT / TOPICAL | 20 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | CREAM / VAGINAL | 13.5 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CREAM / TOPICAL | 0.02 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SPRAY, METERED / SUBLINGUAL | 110 mg | ||
| CETYL PALMITATE | CETYL PALMITATE | 5ZA2S6B08X | SOLUTION / TOPICAL | 0.05 %w/w | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 990.3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SUPPOSITORY / RECTAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| CETYL PALMITATE | CETYL PALMITATE | 5ZA2S6B08X | CREAM / TOPICAL | 0.32 %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 |
|---|---|---|---|---|---|---|
| c29c43c4-85ca-4e18-8e80-eb0bc7cd20cd | 8bd538db-e858-4933-a2ce-1f2f60200254 | 2011-11-13 | Warnings | c29c43c4-85ca-4e18-8e80-eb0bc7cd20cd 8bd538db-e858-4933-a2ce-1f2f60200254 |
Adverse event summaries are temporarily unavailable. Other product information remains available.