Strivectin Advanced Spf Full Screen
FDA Label NDC 54291-051

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Canadian Custom Packaging Company for the product Strivectin Advanced Spf Full Screen (NDC 54291-051). 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 active ingredients, purpose, uses, warnings, keep out of reach of children., otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 8.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact

a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Apply generously 15 minutes before sun exposure and as needed
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats,and sunglasses
  • children under 6 months of age: ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Isohexadecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Polyester-8, Polymethylsilsesquioxane/Silica Crosspolymer, Glyceryl Dibehenate, VP/Hexadecene Copolymer, Fragrance (Parfum), Myristyl Nicotinate, Glycine Soja (Soybean) Oil, Tocopherol, Argania Spinosa (Argan) Kernel Oil, Bis(Cyano Butylacetate) Anthracenediylidene, Polyglyceryl-3 Diisostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Cocos Nucifera (Coconut) Oil, Brassica Campestris (Rapeseed) Seed Oil, Quercus Suber Bark Extract, Retinyl Palmitate, Glycyrrhiza Glabra (Licorice) (Licorice) Root Extract, 7-Dehydrocholesterol, Ascorbyl Palmitate, Oak Root Extract, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Limonene, Citral, Linalool

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