Fruit Smoothies

Manufacturer: Blistex Inc.
Effective date: 2014-06-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:39

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 ingredients	Purpose
Dimethicone 1.0% (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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-8014-1

SPF 15

Blistex_®

LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies_®

4 Creamy Blends With Delicious
Fruit Flavors And Vitamins C&E

FREE
Orange
Cream
LIMITED EDITION
STICK

4 Sticks Net Wt. 0.10 oz. (2.83 g) Ea.

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10157-8014-1	2020-01-31	C162847	48780-1	9d75b9d0-1b9d-f424-e053-dadaa90a57ce	Fruit Smoothies ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10157-8014-1	Fruit Smoothies	1 in 1 BLISTER PACK	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10157-8014	FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]	1	Legacy NDC, 1 package rows	20140701_4572ab3e-0d88-40e1-8769-929b9978aa1d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
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

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

Fruit Smoothies
Dimethicone, Octinoxate, and Oxybenzone
Fruit Smoothies Orange Cream
Dimethicone
Octinoxate
Oxybenzone
aluminum oxide
yellow wax
diethylhexyl adipate
glyceryl monostearate
ethylhexyl palmitate
isopropyl myristate
microcrystalline wax
myristyl myristate
phenoxyethanol
ethylhexyl stearate
silicon dioxide
hydrogenated coconut oil
isopropyl palmitate
isopropyl stearate
tetrahexyldecyl ascorbate
titanium dioxide
phenyl trimethicone
high density polyethylene
saccharin
.alpha.-tocopherol acetate
Fruit Smoothies Triple Tropical
D&C red no. 30
D&C yellow no. 10
Fruit Smoothies Melon Medley
FD&C blue no. 1
Fruit Smoothies Berry Explosion

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10157-8014	10157-8014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 98 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
aluminum oxide	LMI26O6933	IACT
yellow wax	2ZA36H0S2V	IACT
diethylhexyl adipate	MBY1SL921L	IACT
glyceryl monostearate	230OU9XXE4	IACT
ethylhexyl palmitate	2865993309	IACT
isopropyl myristate	0RE8K4LNJS	IACT
microcrystalline wax	XOF597Q3KY	IACT
myristyl myristate	4042ZC00DY	IACT
phenoxyethanol	HIE492ZZ3T	IACT
ethylhexyl stearate	EG3PA2K3K5	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
hydrogenated coconut oil	JY81OXM1OM	IACT
isopropyl palmitate	8CRQ2TH63M	IACT
isopropyl stearate	43253ZW1MZ	IACT
tetrahexyldecyl ascorbate	9LBV3F07AZ	IACT
titanium dioxide	15FIX9V2JP	IACT
phenyl trimethicone	DR0K5NOJ4R	IACT
high density polyethylene	UG00KM4WR7	IACT
saccharin	FST467XS7D	IACT
.alpha.-tocopherol acetate	9E8X80D2L0	IACT
Dimethicone	92RU3N3Y1O	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
aluminum oxide	LMI26O6933	IACT
yellow wax	2ZA36H0S2V	IACT
diethylhexyl adipate	MBY1SL921L	IACT
glyceryl monostearate	230OU9XXE4	IACT
ethylhexyl palmitate	2865993309	IACT
isopropyl myristate	0RE8K4LNJS	IACT
microcrystalline wax	XOF597Q3KY	IACT
myristyl myristate	4042ZC00DY	IACT
phenoxyethanol	HIE492ZZ3T	IACT
ethylhexyl stearate	EG3PA2K3K5	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
hydrogenated coconut oil	JY81OXM1OM	IACT
isopropyl palmitate	8CRQ2TH63M	IACT
isopropyl stearate	43253ZW1MZ	IACT

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 5 · 270 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
yellow wax	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUPPOSITORY / RECTAL	0.11 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SUSPENSION / ORAL		76 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET / ORAL	50 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
saccharin	SACCHARIN	FST467XS7D	SOLUTION / ORAL		150 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
saccharin	SACCHARIN	FST467XS7D	SYRUP / ORAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
hydrogenated coconut oil	HYDROGENATED COCONUT OIL	JY81OXM1OM	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CREAM / TOPICAL	54.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, LIQUID FILLED / ORAL	1.51 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
D&C red no. 30	D&C RED NO. 30	2S42T2808B	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOAP / TOPICAL	1.4 %w/w		Exact identifier — unii candidate 31 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM, EXTENDED RELEASE / TRANSDERMAL	187.5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8a58af07-0eaa-4522-b8f1-a5ee7ae7d530			4572ab3e-0d88-40e1-8769-929b9978aa1d	2014-06-16	Warnings	Exact identifier spl id: 8a58af07-0eaa-4522-b8f1-a5ee7ae7d530 spl set id: 4572ab3e-0d88-40e1-8769-929b9978aa1d

Reported adverse events (FAERS/openFDA)#

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