Fruit Smoothies

Manufacturer
Blistex Inc.
Effective date
2013-08-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:32

Label at a glance#

ProductFruit Smoothies
Active ingredientDimethicone, Octinoxate, Oxybenzone
Label structure8 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn

Dosage and administration

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

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

PACKAGE WARNING

SPL UNCLASSIFIED SECTION

CHOKING HAZARD. Has removable cap. Not for children under 3 years.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

alumina1, bis-PEG-12 dimethicone beeswax, blue 1 lake1, butylparaben, C20-40 pareth-3, ethylparaben, flavors, fruit extracts, glycerin, glyceryl stearate, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate1, lecithin, methylparaben, microcrystalline wax, myristyl myristate, ozokerite, panthenol, pantothenic acid polypeptide, polybutene, polyhydroxystearic acid1, propylparaben, purified water, red 30 lake1, silica1, sodium saccharin, squalane, sucralose, tetrahexyldecyl ascorbate, titanium dioxide1, tridecyl neopentanoate, triisononanoin, yellow 101

1 May contain one or more of these ingredients.

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-9883-6

SPF 15

Blistex®
LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies
®

4 Creamy Blends with Natural
Fruit Extracts, Flavors & Vitamins

FREE
Orange
Cream

LIMITED EDITION
STICK

4 STICKS NET WT. .10 oz (2.83g) EACH

PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack
PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10157-9883-62019-11-27C16284748780-19855d018-e51f-cd31-e053-dbdaa90ab51aBlistex (Fruit Smoothies)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9883-6Fruit Smoothies1 in 1 BLISTER PACKKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9883FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1Legacy NDC, 1 package rows20130814_1216c025-8e8d-4919-857d-da22b309681a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1O1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
DimethiconeACTIVE MOIETY92RU3N3Y1O1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
aluminum oxideINACTIVE INGREDIENTLMI26O69331
butylparabenINACTIVE INGREDIENT3QPI1U3FV81
C20-40 pareth-3INACTIVE INGREDIENT68103A23TQ1
ceresinINACTIVE INGREDIENTQ1LS2UJO3A1
D&C red no. 30INACTIVE INGREDIENT2S42T2808B1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3G1
ethylparabenINACTIVE INGREDIENT14255EXE391
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBD1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
hydrogenated castor oilINACTIVE INGREDIENTZF94AP8MEY1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJS1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KY1
myristyl myristateINACTIVE INGREDIENT4042ZC00DY1
panthenolINACTIVE INGREDIENTWV9CM0O67Z1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
squalaneINACTIVE INGREDIENTGW89575KF91
sucraloseINACTIVE INGREDIENT96K6UQ3ZD41
tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZ1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
tridecyl neopentanoateINACTIVE INGREDIENT3Z8H1DA7J51
triisononanoinINACTIVE INGREDIENTXF4K22WN6T1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-988310157-9883-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 106 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 9 · 525 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHEMULSION / TOPICAL0.06 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii candidate
18 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GSYRUP / ORAL4 mgExact identifier — unii candidate
31 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHJELLY / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET, DELAYED RELEASE / ORAL1337 mgExact identifier — unii candidate
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii candidate
31 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii candidate
31 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii candidate
68 equally ranked IID candidates
hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
12 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSGEL / TRANSDERMAL85 mgExact identifier — unii candidate
18 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / SUBLINGUAL0.23 mgExact identifier — unii candidate
31 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET, EXTENDED RELEASE / ORAL393 mgExact identifier — unii candidate
12 equally ranked IID candidates

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c9521cb-2296-4468-8213-ca0a50b6ed1a1216c025-8e8d-4919-857d-da22b309681a2013-08-09WarningsExact identifier
spl id: 9c9521cb-2296-4468-8213-ca0a50b6ed1a
spl set id: 1216c025-8e8d-4919-857d-da22b309681a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.