FDA.reportPublic FDA data

VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15

Manufacturer
The Body Shop, Wake Forest
Effective date
2016-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:41

Label at a glance#

ProductVITAMIN E MOISTURE-PROTECT LIP CARE SPF 15
Active ingredientOctisalate, Avobenzone, Octocrylene
Label structure8 sections

Indications and uses

helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. 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 sun especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses. reapply this pr...

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
Avobenzone (2.0% w/w)Sunscreen
Octisalate (5.0% w/w)Sunscreen
Octocrylene (3.0% w/w)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn.

Warnings

WARNINGS SECTION

  • For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • 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 sun especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • reapply this product at least every 2 hours.
  • use 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

Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Hydrogenated Coconut Oil, Euphorbia Cerifera (Candelilla) Wax, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Ammonium Glycyrrhizate, Triticum Vulgare (Wheat) Germ Oil, Vanilla Planifolia Fruit Extract, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.

PRINCIPAL DISPLAY PANEL - 4.2 g Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THE
BODY
SHOP®

THE BODY SHOP
VITAMIN E
MOISTURE-PROTECT
LIP CARE

BROADSPECTRUM SPF 15
SUNSCREEN

WITH VITAMIN E
& MOISTURISING WHEATGERM OIL

ACTIVE INGREDIENTS:
Avobenzone (2.0%),
Octisalate (5.0%),
Octocrylene (3.0%).

Net wt. 4.2 g (0.14 OZ)

ALL SKIN TYPES

Peel for Drug Facts

Principal Display Panel - 4.2 g Container
Principal Display Panel - 4.2 g Container

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57691-002-422020-01-31C16284748780-19d75b9d0-1f33-f424-e053-dadaa90a57ceVITAMIN E MOISTURE-PROTECT LIP CARE SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57691-002-42VITAMIN E MOISTURE-PROTECT LIP CARE SPF 154.2 g in 1 CONTAINERSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57691-002VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 (OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) STICK [THE BODY SHOP, WAKE FOREST]1Legacy NDC, 1 package rows20160414_16dd7500-92c1-4c9d-84d2-e9294e2f415b.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57691-00257691-002-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
Octocrylene5A68WGF6WMACTIB
CASTOR OILD5340Y2I9GIACT
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
Hydrogenated Coconut OilJY81OXM1OMIACT
CANDELILLA WAXWL0328HX19IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Ammonium Glycyrrhizate3VRD35U26CIACT
WHEAT GERM OIL14C97E680PIACT
VanillaQ74T35078HIACT
Calendula Officinalis FlowerP0M7O4Y7YDIACT
Echinacea PurpureaQI7G114Y98IACT
TocopherolR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT

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
931da763-2cf8-407d-a76a-e52d3341779816dd7500-92c1-4c9d-84d2-e9294e2f415b2016-03-18WarningsExact identifier
spl id: 931da763-2cf8-407d-a76a-e52d33417798
spl set id: 16dd7500-92c1-4c9d-84d2-e9294e2f415b

Reported adverse events (FAERS/openFDA)#

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