Soft Derm Intensive Defense 8 Spf
FDA Label NDC 75870-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios De Cosmetica Scientifica Atache Sa for the product Soft Derm Intensive Defense 8 Spf (NDC 75870-002). 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 description, instructions for use, warnings, otc - active ingredient, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Description

CALMING FACIAL EMULSION DAY

Balanced facial emulsion.  Specifically created for the care of sensitive skin, with effects that are relaxing, cleaning, restoring, and protective.

Instructions For Use

Directions:  After cleansing and toning the skin, gently massage into the skin until fully absorbed.


Warnings

Warnings:  For external use only.  Keep out of reach of children.  Avoid contact with eyes.  Discontinue use if signs of irritation or rash appear.


Otc - Active Ingredient

ACTIVE INGREDIENTS:

OCTINOXATE 20% - sunscreen

TITANIUM DIOXIDE 14% - sunscreen

Inactive Ingredient

OTHER INGREDIENTS:  AQUA (THERMAL WATER), ICTYLDODECYL MYRISTATE, PEG-6 STEARATE, GLYCERIN, C12-15 ALKYL BENZOATE, CETYL ALCOHOL, DIMETHICONE, ALOE BARBADENSIS GEL 10:1, CAPPARIS SPINOSA FRUIT EXTRACT, HYDROLYZED ENTEROMORPHA COMPRESSA EXTRACT, CETETH-20, GLYCERYL STEARATE, STEARETH-20, XANTUAN GUM, ALLANTOIN, BUTYLENE GLYCOL, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINUM OXIDE, DISODIUM EDTA, PHENOXYETANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, DIMENTICONE CROSSPOLYMER, BHT, PERFUM.

Package Label.Principal Display Panel



* Please review the disclaimer below.