Indications and uses
temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn
temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn
apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor
protect the product in this container from excessive heat and direct sun
Drug Facts
| Active ingredients | Purpose |
|---|---|
| Dimethicone 1.0% (w/w) | Lip protectant |
| Octinoxate 7.5% (w/w) | Sunscreen |
| Oxybenzone 2.5% (w/w) | Sunscreen |
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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 a doctor if rash occurs
CHOKING HAZARD. Has removable cap. Not for children under 3 years.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
alumina, beeswax, blue 1 lake1, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, isopropyl palmitate, isopropyl stearate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyethylene, polyhydroxystearic acid, red 30 lake1, saccharin, silica, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate, yellow 101
1 May contain one or more of these ingredients.
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10157-8009-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-db82-f424-e053-dadaa90a57ce | Fruit Smoothies ® |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10157-8009-1 | Fruit Smoothies | 1 in 1 BLISTER PACK | KIT | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10157-8009 | FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.] | 1 | Legacy NDC, 1 package rows | 20130904_38d7b411-41e3-406f-be6a-9d65272d6a45.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dimethicone | ACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Dimethicone | ACTIVE MOIETY | 92RU3N3Y1O | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| .alpha.-tocopherol acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| D&C red no. 30 | INACTIVE INGREDIENT | 2S42T2808B | 1 | |
| D&C yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| diethylhexyl adipate | INACTIVE INGREDIENT | MBY1SL921L | 1 | |
| ethylhexyl palmitate | INACTIVE INGREDIENT | 2865993309 | 1 | |
| ethylhexyl stearate | INACTIVE INGREDIENT | EG3PA2K3K5 | 1 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| high density polyethylene | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| hydrogenated coconut oil | INACTIVE INGREDIENT | JY81OXM1OM | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| isopropyl palmitate | INACTIVE INGREDIENT | 8CRQ2TH63M | 1 | |
| isopropyl stearate | INACTIVE INGREDIENT | 43253ZW1MZ | 1 | |
| microcrystalline wax | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| myristyl myristate | INACTIVE INGREDIENT | 4042ZC00DY | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| phenyl trimethicone | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| saccharin | INACTIVE INGREDIENT | FST467XS7D | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| tetrahexyldecyl ascorbate | INACTIVE INGREDIENT | 9LBV3F07AZ | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| yellow wax | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10157-8009 | 10157-8009-1 |
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 |
|---|---|---|---|---|---|---|
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOLUTION / ORAL | 8 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE / ORAL | 20 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, DELAYED RELEASE / ORAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| saccharin | SACCHARIN | FST467XS7D | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | OINTMENT / OPHTHALMIC | NA | ||
| saccharin | SACCHARIN | FST467XS7D | DROPS / ORAL | 20 mg/1ml | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| saccharin | SACCHARIN | FST467XS7D | TABLET, CHEWABLE / ORAL | 0.9 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOAP / TOPICAL | 1.4 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | CREAM / TOPICAL | 54.5 %w/w | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, CHEWABLE / ORAL | 1 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| .alpha.-tocopherol acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, DELAYED RELEASE / ORAL | 1.9 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GUM, CHEWING / BUCCAL | 24 mg | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | OINTMENT / TOPICAL | 94 %w/w | ||
| isopropyl palmitate | ISOPROPYL PALMITATE | 8CRQ2TH63M | LOTION / TOPICAL | 5 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| saccharin | SACCHARIN | FST467XS7D | PASTE, DENTIFRICE / DENTAL | 0.23 %w/w | ||
| D&C red no. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, COATED / ORAL | 1.16 mg | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | PASTE / TOPICAL | 2.5 %w/w | ||
| isopropyl palmitate | ISOPROPYL PALMITATE | 8CRQ2TH63M | FILM, EXTENDED RELEASE / TRANSDERMAL | 187.5 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 |
|---|---|---|---|---|---|---|
| b1492fa2-6f92-4bf8-8270-e5b01d5217af | 38d7b411-41e3-406f-be6a-9d65272d6a45 | 2013-09-03 | Warnings | b1492fa2-6f92-4bf8-8270-e5b01d5217af 38d7b411-41e3-406f-be6a-9d65272d6a45 |
Adverse event summaries are temporarily unavailable. Other product information remains available.