Sun Premium Face 50 Spf
FDA Label NDC 75870-006

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 Sun Premium Face 50 Spf (NDC 75870-006). 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 package label.principal display panel, description, instructions for use, warnings, otc - active ingredient, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label.Principal Display Panel

ATACHE

SCIENTIFIC COSMETIC

SUN PREMIUM


FACE
50+ SPF
UVA-UVB

VERY
HIGH

COLOR

ANTIAGE PROTECTIVE FACE CREAM
WITH COLOR

75 ml e  2.53 FL OZ

Enter section text here

Description

ANTIAGE PROTECTIVE FACE CREAM

WITH COLOR


Innovative combination of a selection of extracts that offer a perfect balance between sun protection and beauty.  A soft, pleasant texture on your skin, that lets you enjoy an even tan while it protects your face from the signs of ageing and gives a firmer appearance.

Instructions For Use

INSTRUCTIONS FOR USE:  Apply evenly to the face and neck half an hour before sunbathing.  Apply again each 1-2 hours or after bathing.

Warnings

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

Otc - Active Ingredient

ACTIVE INGREDIENTS:

OXYBENZONE 5% - sunscreen

OCTINOXATE 5% - sunscreen

AVOBENZONE 2% - sunscreen

TITANIUM DIOXIDE 1.5% - sunscreen



Inactive Ingredient

OTHER INGREDIENTS:   AQUA (WATER), ALOE VERA GEL, UREA, CETEARYL ALCOHOL, GLLYCERIN, C12-20 ALKYL BENZOATE, ISOHEXADECANE, TRIETHYLEXANOIN, CETYL PALMITATE, DIMETHICONE, TRIMETHOXYCAPRYLYLSILANE, STEARETH-2, BUTYROSPERMUM PARK II (SHEA BUTTER), PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, CYCLOMETHICONE, DIMETHICONOL, CETETH-25, PEG-0 STEARATE, BEHENYL ALCOHOL, SODIUM PCA, GLYCERETH-26, STEARETH-21, SQUALANE, PARAFFIN, DIAZOLIDINYL UREA, ECHINACEA ANTUSTIFOLIA EXTRACT, CENTELLA ASIATICA EXTRACT, FUCUS VESICULOSUS EXTRACT, TRIGONELLA FOENUM-GRAECUM SEED EXTRACT, PROPYLENE GLYCOL, PEG-20 CASTOR OIL, ALCOHOL DENAT, PEG-60 HYDROGENATED CASTOR OIL, CALCIUM PANTOTHENATE, INOSITOL, BIOTIN, RETINOL, TOCOPHERYL ACETATE, GLYCERYL LINOLEATE, GLYCERYL LINOLENATE, GLYCERYL ARACHIDONATE, ALUMINIUM STEARATE, ALUMINA, XANTHAN GUM, ALLANTOIN, COCOS NUCIFERA (COCONUM OIL), GARDENIA TAHITENSIS (TIARE FLOWER), PARFUM (FRAGRANCE), LIMONENE, LINALOOL, TETRASODIUM EDTA, POLYHYDROXYESTEARIC ACID, TOCOPHERYL ACETATE, DIPALMITOYL HYDROXYPROLINE.


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