The Sof Fluid Long Wear Foundation Broad Spectrum Spf 20 Liquid
FDA Label NDC 65966-018

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Max Huber Research Lab Inc for the product The Sof Fluid Long Wear Foundation Broad Spectrum Spf 20 (NDC 65966-018). 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, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Active Ingredients

Octinoxate 7.5%
Titanium dioxide 1.9%

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

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 a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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

Inactive Ingredients

DECLUSTERED WATER (-)\AQUA\EAU DE-STRUCTUREE (-) • DECLUSTERED WATER (+)\AQUA\EAU DE-STRUCTUREE (+) • CYCLOPENTASILOXANE • ISODODECANE • DIMETHICONE • PHENYL TRIMETHICONE • BUTYLENE GLYCOL • POLYMETHYL METHACRYLATE • POLYSILICONE-11 • COCO-CAPRYLATE/CAPRATE • PEG/PPG-18/18 DIMETHICONE • OCTYLDODECYL NEOPENTANOATE • SILICA • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • POLYGLYCERYL-4 ISOSTEARATE • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • MOLASSES EXTRACT\SACCHARUM OFFICINARUM\EXTRAIT DE MELASSE • CHLORELLA VULGARIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • CORALLINA OFFICINALIS EXTRACT • SACCHAROMYCES LYSATE EXTRACT • SILYBUM MARIANUM (LADY'S THISTLE) EXTRACT • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • LAMINARIA SACCHARINA EXTRACT • CODIUM TOMENTOSUM EXTRACT • SUCROSE • GLYCERIN • CHOLESTEROL • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • GLYCINE SOJA (SOYBEAN) PROTEIN • ACETYL GLUCOSAMINE • CAFFEINE • SORBITOL • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • TOURMALINE • ACETYL HEXAPEPTIDE-8 • SODIUM HYALURONATE • HEXYL LAURATE • CETYL PEG/PPG-10/1 DIMETHICONE • DISTEARDIMONIUM HECTORITE • C12-16 ALCOHOLS • MAGNESIUM ALUMINUM SILICATE • TREHALOSE • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • DIMETHICONE SILYLATE • PROPYLENE GLYCOL DIETHYLHEXANOATE • YEAST POLYSACCHARIDES • CAPRYLYL GLYCOL • TRIETHYL CITRATE • TETRAHEXYLDECYL ASCORBATE • STEARIC ACID • PALMITIC ACID • HYDROGENATED LECITHIN • METHICONE • PROPYLENE GLYCOL DICAPRATE • TOCOPHERYL LINOLEATE/OLEATE • SODIUM CHLORIDE • ALUMINUM HYDROXIDE • HEXYLENE GLYCOL • TRIETHOXYCAPRYLYLSILANE • FRAGRANCE (PARFUM) • ALCOHOL DENAT. • DISODIUM EDTA • BHT • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499)] <ILN42899>

Other Information

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

Principal Display Panel - 30 Ml Bottle Carton

SKINCOLOR DE LA MER™

LA MER

the soft fluid
long wear foundation
broad spectrum SPF 20

net wt. 1 oz./30 ml e

Principal Display Panel (30 ml Bottle Carton)

Principal Display Panel (30 ml Bottle Carton)

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