Societe Prime And Defend Cream
FDA Label NDC 87700-539

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Societe Clinical Skincare for the product Societe Prime And Defend (NDC 87700-539). 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, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Titanium Dioxide 10.60%

Zinc Oxide 3.85%

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash and irritation develops and lasts. Avoid contact with eyese. If product gets into eyes, rinse thoroughly with water.

Directions

Apply evenly to skin before exposure to sun and as needed. Children under 6 months, ask doctor. Reapply as needed or after towel drying or swimming

Inactive Ingredients

Cyclopentasiloxane
Dimethicone Crosspolymer
Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer
Dimethicone/Vinyl Dimethicone Crosspolymer
Melanin
Tribehenin
Calcium Behenate
Sorbitan Isostearate
Dimethiconol
Cyclotetrasiloxane
Alumina
PEG-10 Dimethicone
Methicone
Camellia Sinensis Leaf Extract
Iron Oxide

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