Fruit Smoothies

Manufacturer: Blistex Inc.
Effective date: 2013-06-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:44

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 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.

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

alumina, bis-PEG-12 dimethicone beeswax, butylparaben, C20-40 pareth-3, ethylparaben, flavors, fruit extracts, glycerin, glyceryl stearate, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, lecithin, methylparaben, microcrystalline wax, myristyl myristate, ozokerite, panthenol, pantothenic acid polypeptide, polybutene, polyhydroxystearic acid, propylparaben, purified water, silica, sodium saccharin, squalane, sucralose, tetrahexyldecyl ascorbate, titanium dioxide, tridecyl neopentanoate, triisononanoin May contain: blue 1 lake, red 30 lake, yellow 10.

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-9883-3

SPF 15

Blistex_®

LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies_®

3 Creamy Blends with Natural
Fruit Extracts, Flavors & Vitamins

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

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
10157-9883-3	2019-11-27	C162847	48780-1	9855d018-e75c-cd31-e053-dbdaa90ab51a	Fruit Smoothies ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10157-9883-3	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
10157-9883	FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]	1	Legacy NDC, 1 package rows	20130620_18442ef1-06a8-4fb1-bcb4-f75361254224.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
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	1
C20-40 pareth-3	INACTIVE INGREDIENT	68103A23TQ	1
ceresin	INACTIVE INGREDIENT	Q1LS2UJO3A	1
D&C red no. 30	INACTIVE INGREDIENT	2S42T2808B	1
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
hydrogenated castor oil	INACTIVE INGREDIENT	ZF94AP8MEY	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
microcrystalline wax	INACTIVE INGREDIENT	XOF597Q3KY	1
myristyl myristate	INACTIVE INGREDIENT	4042ZC00DY	1
panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
squalane	INACTIVE INGREDIENT	GW89575KF9	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
tetrahexyldecyl ascorbate	INACTIVE INGREDIENT	9LBV3F07AZ	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
tridecyl neopentanoate	INACTIVE INGREDIENT	3Z8H1DA7J5	1
TRIISONONANOIN	INACTIVE INGREDIENT	XF4K22WN6T	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

Fruit Smoothies
Dimethicone, Octinoxate, and Oxybenzone
Fruit Smoothies Melon Medley
Dimethicone
Octinoxate
Oxybenzone
aluminum oxide
C20-40 pareth-3
glycerin
glyceryl monostearate
hydrogenated castor oil
isopropyl myristate
microcrystalline wax
myristyl myristate
panthenol
TRIISONONANOIN
silicon dioxide
saccharin sodium
squalane
sucralose
tetrahexyldecyl ascorbate
titanium dioxide
tridecyl neopentanoate
water
FD&C blue no. 1
D&C yellow no. 10
ceresin
PROPYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
METHYLPARABEN
Fruit Smoothies Triple Tropical
D&C red no. 30
Fruit Smoothies Berry Explosion

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10157-9883	10157-9883-3

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 84 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
aluminum oxide	LMI26O6933	IACT
C20-40 pareth-3	68103A23TQ	IACT
glycerin	PDC6A3C0OX	IACT
glyceryl monostearate	230OU9XXE4	IACT
hydrogenated castor oil	ZF94AP8MEY	IACT
isopropyl myristate	0RE8K4LNJS	IACT
microcrystalline wax	XOF597Q3KY	IACT
myristyl myristate	4042ZC00DY	IACT
panthenol	WV9CM0O67Z	IACT
TRIISONONANOIN	XF4K22WN6T	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
saccharin sodium	SB8ZUX40TY	IACT
squalane	GW89575KF9	IACT
sucralose	96K6UQ3ZD4	IACT
tetrahexyldecyl ascorbate	9LBV3F07AZ	IACT
titanium dioxide	15FIX9V2JP	IACT
tridecyl neopentanoate	3Z8H1DA7J5	IACT
water	059QF0KO0R	IACT
FD&C blue no. 1	H3R47K3TBD	IACT
D&C yellow no. 10	35SW5USQ3G	IACT
ceresin	Q1LS2UJO3A	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ETHYLPARABEN	14255EXE39	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
Dimethicone	92RU3N3Y1O	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
aluminum oxide	LMI26O6933	IACT
C20-40 pareth-3	68103A23TQ	IACT
glycerin	PDC6A3C0OX	IACT
glyceryl monostearate	230OU9XXE4	IACT
hydrogenated castor oil	ZF94AP8MEY	IACT
isopropyl myristate	0RE8K4LNJS	IACT
microcrystalline wax	XOF597Q3KY	IACT
myristyl myristate	4042ZC00DY	IACT
panthenol	WV9CM0O67Z	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 9 · 525 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / DENTAL	NA		Exact identifier — unii candidate 31 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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 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
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 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	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
D&C red no. 30	D&C RED NO. 30	2S42T2808B	CAPSULE / ORAL	0.1 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / SUBLINGUAL	0.23 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	PASTE / DENTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 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	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	OINTMENT / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER / ORAL		48 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
D&C red no. 30	D&C RED NO. 30	2S42T2808B	TABLET, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 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
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 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
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 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
73563d35-3cbd-49b1-810d-87a09ce849ef			18442ef1-06a8-4fb1-bcb4-f75361254224	2013-06-18	Warnings	Exact identifier spl id: 73563d35-3cbd-49b1-810d-87a09ce849ef spl set id: 18442ef1-06a8-4fb1-bcb4-f75361254224

Reported adverse events (FAERS/openFDA)#

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