FDA.reportPublic FDA data

elave Age Delay Daily Lip Defence

Manufacturer
Ovelle Ltd
Effective date
2011-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:22

Label at a glance#

Productelave Age Delay Daily Lip Defence SPF20
Active ingredientOctinoxate, Zinc Oxide
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS


ACTIVE INGREDIENTS                               PURPOSE

Octinoxate 7.5%w/w                                   Sunscreen

Zinc Oxide 4.0%w/w                                   Sunscreen

OTC - PURPOSE SECTION

USES

  • helps protect against sunburn
  • for lips that sunburn easily
  • helps provide protection against UVA and UVB rays

WARNINGS SECTION

WARNINGS

For external use only

Do not use on

  • broken skin
  • serious burns
When using this product

  • keep out of the eyes. Rinse with water to remove
  • not suitable for ingestion
Stop use and ask a doctor if

  • rash or irritation develops and lasts
Keep out of reach of children

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

OTC - WHEN USING SECTION

DIRECTIONS


  • apply to lips 15 - 20 minutes before sun exposure
  • re-apply as needed, especially after prolonged sun exposure, drinking or eating

OTHER SAFETY INFORMATION

OTHER INFORMATION

  • store below 25C, do not freeze
  • not recommended for children under 6 months of age

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Cera Alba (Beeswax), Oryza Sativa (Rice) Bran Wax, Butyrospermum Parkii (Shea Butter), Stearyl Dimethicone, Copernicia Cerifera (Carnauba) Wax, Dipalmitoyl Hydroxyproline, Phenyl Trimethicone, Bixa Orellana Seed Oil, Mentha Piperita (Peppermint Oil), Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, BHT, Triethoxycaprylylsilane

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS

Distributor: Ashette LLC, 27-28 Thomson Ave, Long Island City NY11101

www.ashette.com

Manufacturer: Ovelle Pharmaceuticals, Coes Road, Dundalk, Co Louth, Ireland

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

age delay daily lip defence

SPF20

Sensitive Formula

Broad-Spectrum UVA/UVB Protection

Preservative Fee

Anti-oxidant Vitamin E

Soothing Aloe Vera Leaf Extract

Triple Firming Natural Lipoamino Acid

Refreshing Peppermint Oil

FREE FROM

Parabens, Alcohol, Sulfates, SLES/SLS, Formaldehyde, Dyes, Colours, Phthalates, Lanolin, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL





4600600201
4600600201

4600600201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46006-002-012019-11-13C16284748780-197449f38-c98c-f6ea-e053-dbdaa90aa703d46f160f-2469-46c4-80a8-050dfb9b3af8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46006-002-01elave Age Delay Daily Lip DefenceSPF2015 mL in 1 TUBEOINTMENT151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46006-002ELAVE AGE DELAY DAILY LIP DEFENCE SPF20 (OCTINOXATE, ZINC OXIDE) OINTMENT [OVELLE LTD]1Legacy NDC, 1 package rows20111220_d46f160f-2469-46c4-80a8-050dfb9b3af8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OctinoxateACTIVE MOIETY4Y5P7MUD511
Zinc OxideACTIVE MOIETYSOI2LOH54Z1

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
46006-00246006-002-01

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
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIB
Castor OilD5340Y2I9GIACT
Hydrogenated Castor OilZF94AP8MEYIACT
Yellow Wax2ZA36H0S2VIACT
Rice BranR60QEP13ICIACT
Shea ButterK49155WL9YIACT
Dimethicone92RU3N3Y1OIACT
Carnauba WaxR12CBM0EIZIACT
Dipalmitoyl HydroxyprolineE6AHA53N1HIACT
Phenyl TrimethiconeDR0K5NOJ4RIACT
Bixa Orellana Seed Oil3R3HS2KR6PIACT
Peppermint OilAV092KU4JHIACT
Alpha-Tocopherol Acetate9E8X80D2L0IACT
Aloe Vera LeafZY81Z83H0XIACT
Coconut OilQ9L0O73W7LIACT
Butylated Hydroxytoluene1P9D0Z171KIACT
TriethoxycaprylylsilaneLDC331P08EIACT

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
761b6fe0-8816-45fb-9629-84cb49af67a6d46f160f-2469-46c4-80a8-050dfb9b3af82011-12-13WarningsExact identifier
spl id: 761b6fe0-8816-45fb-9629-84cb49af67a6
spl set id: d46f160f-2469-46c4-80a8-050dfb9b3af8

Reported adverse events (FAERS/openFDA)#

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