Fusion Water Magic Lotion
FDA Label NDC 69494-016

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Isdin Corp. for the product Fusion Water Magic (NDC 69494-016). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Octocrylene 9%Sunscreen
Homosalate 7.3%Sunscreen
Octisalate 4.5%Sunscreen
Avobenzone 2.7%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

Otc - Do Not Use

  • Do not use
    • on damaged or broken skin

Otc - When Using

  • When using this product
    • keep out of eyes. Rinse with water to remove

Otc - Stop Use

  • Stop use and ask doctor
    • if rash occurs

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

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: ask a doctor
  • Sun Protection Measures: Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats and sunglasses

Other Information

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

Inactive Ingredients

Water, Dimethicone, Silica, Butyloctyl Salicylate, Propanediol, Lauryl PEG/PPG-18/18 Methicone, Poly C10-30 Alkyl Acrylate, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Hydroxyacetophenone, Potassium Cetyl Phosphate, VP/Eicosene Copolymer, Polysorbate 60, Glycerin, Caprylyl Glycol, Tocopheryl Acetate, Polyacrylate Crosspolymer-6, Styrene/Acrylates Copolymer, Tetrasodium Glutamate Diacetate, Fragrance, Hydrated Silica, Sclerotium Gum, Sodium Hyaluronate, Xanthan Gum, Porphyridium Cruentum Extract, Caprylic/Capric Triglyceride, Physalis Pubescens Fruit Juice, Sodium Hydroxide, T-Butyl Alcohol, Tocopherol, Citric Acid

Questions Or Comments?

Call (862) 242-8129 Monday – Friday (9 a.m. to 5 p.m. EST) or visit www.isdin.com

Principal Display Panel - 50 Ml Bottle Carton

ISDIN

Fusion Water
MAGIC™

DAILY
PROTECTION

SPF 40 BROAD SPECTRUM
DAILY USE SUNSCREEN
WITH MEDITERRANEAN ALGAE
1.7 FL OZ (50 mL)

Principal Display Panel (50 mL Bottle Carton)

Principal Display Panel (50 mL Bottle Carton)

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