Dimethicone, Octinoxate, Octisalate, Avobenzone, and Oxybenzone

Manufacturer
Blistex Inc
Effective date
2019-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:50:22

Label at a glance#

ProductEnhancement Series (Blistex Soft and Lush, Blistex Deep Renewal, Blistex Ultra-Rich Hydration)
Active ingredientDimethicone, Octinoxate, OCTISALATE, AVOBENZONE
Label structure22 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

SOFT & LUSH®

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (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

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, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, C12-15 alkyl benzoate, caprylic/capric triglyceride, ceramide NG, ceresin, cetyl dimethicone, cetyl palmitate, flavors, glyceryl laurate, hydrogenated castor oil, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, palmitoyl hexapeptide-12, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, titanium dioxide, tribehenin

SPL UNCLASSIFIED SECTION

DEEP RENEWAL®

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3.0% (w/w)Sunscreen
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (w/w)Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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.

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
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long sleeve shirts, pants, hats, and sunglasses
  • 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

atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavors, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, pentylene glycol, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone

SPL UNCLASSIFIED SECTION

ULTRA-RICH HYDRATION®

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (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

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, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, ceresin, cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, theobroma cacao (cocoa) seed butter, titanium dioxide, tocopheryl acetate, triticum vulgare (wheat) germ oil

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

soft • youthful • smooth

BUY 2 GET 1 FREE

SPF15

BROAD SPECTRUM
SPF15

SPF15

3 Sticks Net Wt. 0.13 oz. (3.69 g) Ea.

PRINCIPAL DISPLAY PANEL - Kit Blister Pack
PRINCIPAL DISPLAY PANEL - Kit Blister Pack

Products#

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

DailyMed product names page 1 of 2 · 66 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-990710157-9907-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 93 matching rows.

Source Document#

Source XML

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
0ca61738-194d-4cbb-8b29-7c2610b8bd165ce66db5-acb0-49fb-8a3c-a4b24cba11e72020-09-15WarningsExact identifier
spl set id: 5ce66db5-acb0-49fb-8a3c-a4b24cba11e7

Reported adverse events (FAERS/openFDA)#

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