Elave Age Delay Daily Lip Defence
FDA Label NDC 46006-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ovelle Ltd for the product Elave Age Delay Daily Lip Defence (NDC 46006-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, other safety information, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

DRUG FACTS


ACTIVE INGREDIENTS                               PURPOSE

Octinoxate 7.5%w/w                                   Sunscreen

Zinc Oxide 4.0%w/w                                   Sunscreen

Otc - Purpose

USES

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

Warnings

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

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

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

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



4600600201 (4600600201)

4600600201 (4600600201)


4600600201



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