FDA.reportPublic FDA data

CHAPSTICK LIPSHIELD 365

Manufacturer
Pfizer Consumer Healthcare | Fareva Richmond, Inc.
Effective date
2011-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:49:56

Label at a glance#

ProductCHAPSTICK LIPSHIELD 365
Active ingredientAVOBENZONE, DIMETHICONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection helps prevent and temporarily protects chafed, chapped or cracked lips

Dosage and administration

apply liberally before sun exposure and as needed children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Dimethicone 1.5%

Homosalate 6%

Octinoxate 6.5%

Octisalate 4.5%

Oxybenzone 5%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

Skin Protectant

Sunscreen

Sunscreen

Sunscreen

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • helps prevent and temporarily protects chafed, chapped or cracked lips

WARNINGS

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • apply liberally before sun exposure and as needed
  • children under 6 months of age: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

alumina, butylene glycol, C12-15 alkyl benzoate, caprylic/capric triglyceride, caprylyl glycol, carnauba wax, castor oil phosphate, cetyl alcohol, colloidal silicon dioxide, diethylhexyl 2,6-naphthalate, ethylhexyl palmitate, hexylene glycol, hydrogenated poly (C6-14 olefin), isopropyl myristate, medium-chain triglycerides, methylparaben, natural and artificial flavor, paraffin, perfluorononyl dimethicone, phenoxyethanol, propylparaben, silica dimethyl silyate, sodium hyaluronate, sorbeth-2 hexaoleate, spilanthes acmella flower extract, sucralose, titanium dioxide, triethoxycaprylysilane, ubiquinone, vitamin E acetate, white wax

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Chapstick LipShield 365

Skin Protectant/Sunscreen SPF 50+

Ingredients known to give superior moisturization

Maximum SPF protection for lips

All Seasons

New advanced formula

NET WT 0.15 OZ (4 g)

Dist. by: Pfizer, Madison, NJ 07940 USA © 2010 Pfizer Inc.

For most recent product information, visit www.chapstick.com

Sealed For Your Protection

Twist Cap To Break Seal

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-1929-122021-05-05C16284748780-19d75b9d0-05b6-f424-e053-dadaa90a57ceChapstick LipShield 365 (avobenzone, dimethicone, homosalate, octinoxate, octisalate, and oxybenzone)
0573-1929-122020-01-31C16284748780-19d75b9d0-05b6-f424-e053-dadaa90a57ceChapstick LipShield 365 (avobenzone, dimethicone, homosalate, octinoxate, octisalate, and oxybenzone)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O2
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
DIMETHICONEACTIVE MOIETY92RU3N3Y1O2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-19290573-1929-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIM
DIMETHICONE92RU3N3Y1OACTIM
HOMOSALATEV06SV4M95SACTIM
OCTINOXATE4Y5P7MUD51ACTIM
OCTISALATE4X49Y0596WACTIM
OXYBENZONE95OOS7VE0YACTIM
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
ETHYLHEXYL PALMITATE2865993309IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYLPARABENA2I8C7HI9TIACT
PARAFFINI9O0E3H2ZEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLPARABENZ8IX2SC1OHIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ACMELLA OLERACEA FLOWER2794N5KM0KIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE WAX7G1J5DA97FIACT

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
eea2d60b-5dea-4581-a875-a2be4bb84a5ab9a1dd35-3333-e73f-2049-27dac85a0d5f2021-04-29WarningsExact identifier
spl set id: b9a1dd35-3333-e73f-2049-27dac85a0d5f

Reported adverse events (FAERS/openFDA)#

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