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  5. Label Information: Elave Age Delay Daily Lip Defence Spf20

FDA Label for Elave Age Delay Daily Lip Defence Spf20

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTHER SAFETY INFORMATION
    6. INACTIVE INGREDIENT
    7. OTC - QUESTIONS
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elave Age Delay Daily Lip Defence Spf20 Product Label

The following document was submitted to the FDA by the labeler of this product Ovelle Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



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