Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum Spf 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight Sunscreen Lotion
FDA Label NDC 69625-651

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetique Active Production for the product Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum Spf 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight Sunscreen (NDC 69625-651). 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, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredients

Titanium dioxide 14.8%

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.

Directions

For sunscreen use:

  • shake well before use

    • ●  apply liberally 15 minutes before sun exposure

    ●  reapply:

        ●  after 80 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 this risk, regularly use a sunscreen 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-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
  • store at 68 – 77° F (20 – 25°C)

Inactive Ingredients

water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

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