Croc Bloc Broad Spectrum Spf 30 Fps Ecran Solaire
FDA Label NDC 58331-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Degil Safety Products (1989) Inc. for the product Croc Bloc Broad Spectrum Spf 30 Fps Ecran Solaire (NDC 58331-030). 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, warnings, otc - stop use, otc - when using, otc - ask doctor, otc - keep out of reach of children, directions, 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 IngredientsPurposes
Homosalate10.5%Sunscreen
Octisalate5.0%Sunscreen
Oxybenzone2.0%Sunscreen
Avobenzone2.0%Sunscreen
Octocrylene2.0%Sunscreen

Warnings

For external use only

Otc - Stop Use

  • Discontinue use if skin irritation develops or increases
  • If irritation persists, consult a health care practitioner

Otc - When Using

  • Avoid contact with eyes
  • If contact occurs, rinse thoroughly with water
    • May stain or damage some fabrics or surfaces

Otc - Ask Doctor

  • Consult a healthcare practitioner prior to use on children less than six months of age

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children

Directions

Shake well. Apply generously 15-30 minutes prior to exposure to the sun. Reapply as needed or after swimming, towel drying, perspiring heavily, washing and vigorous activity.

Other Ingredients

Aqua, Sorbitan Isostearate, Sorbitol, Triethanolamine, Polyglyceryl-3 Distearate, Stearic Acid, Octadecene/MA Copolymer, Barium Sulfate, Benzyl Alcohol, VP/Eicosene Copolymer, Dimethicone, Carbomer, Methyl-paraben, Aloe Barbadensis Leaf Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol, Propylparaben, Disodium EDTA

Principal Display Panel - 120 Ml Bottle Label

Sunscreen

SPF 30 FPS

BROAD SPECTRUM • LARGE SPECTRE
UVA/UVB PROTECTION

Unscented • Water & Sweat Resistant
Dermatologist Tested • Moisturizing Aloe & Vitamin E

DIN XXXXXXXX
Net Contents : 4 fl. oz. (120 mL)

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