Solara Suncare - Clean Freak Lotion
FDA Label NDC 73054-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Solara Suncare, Inc. for the product Solara Suncare - Clean Freak (NDC 73054-102). 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, otc - keep out of reach of children, directions, inactive ingredients, other information, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Non-Nano, Non-Coated Zinc Oxide 20%

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

Otc - Keep Out Of Reach Of Children

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

Directions

  • shake or knead before each use
  • apply generously and evenly 15 minutes before sun exposure
  • reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use asunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C13-14 Alkane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate, Propanediol, Cocos Nucifera (Coconut) Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Withania Somnifera (Ashwagandha) Root Extract, Perilla Frutescens (Mint) Leaf Extract, Punica Granatum Flower Extract, Prunus Amygdalus Dulcis (Sweet Almond) Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Impatiens Balsamina Flower Extract, Potassium Sorbate, Terminalia Ferdinandiana Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera Fruit Extract, Cucumis Melo Cantalupensis Fruit Extract, Dianthus Caryophyllus Flower Extract, Fragaria Ananassa (Strawberry) Fruit
Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Musa Sapientum (Banana) Fruit Extract, Vanilla Planifolia Fruit Extract, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Cetyl Palmitate, Sorbitan Palmitate, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Fructose, Benzyl Salicylate*, Amyl Cinnamal*, Hexyl Cinnamal*, Coumarin*, Linalool* (*0.004% or less, naturally occurring in plant extracts)

Other Information

  • Protect this product from excessive heat and direct sun.

Questions Or Comments

  • 1-855-859-1600 (9am – 5pm ET)

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