65c589fe-ca80-4a4b-a811-262bda81d3d1

SPL v1
SPL
SPL Set ID 65c589fe-ca80-4a4b-a811-262bda81d3d1
Route
topical
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (0.55 g)
Inactive Ingredients
diisostearyl malate dimethicone

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-06-01

Purpose

Purpose: Sunscreen

Description

Active Ingredient: Titanium Dioxide 11.03%


Medication Information

Warnings

Warnings: KEEP OUT OF EYES. STOP USING IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

Purpose

Purpose: Sunscreen

Description

ATTENTION: EVITER TOUT CONTACT AVEC LES YEUX. SUSPENDRE L’UTILISATION EN CAS D’IRRITATION. TENIR HORS DE PORTEE DES ENFANTS.

ATENCION: EVITE QUE ENTRE EN LOS OJOS. INTERRUMPA SU USO SI SE PRODUCE IRRITACION. MANTENER FUERA DES ALCANCE DE LOS NINOS.

How to use: APPLY AN ADEQUATE AMOUNT EVENLY OVER ENTIRE FACE.

Active Ingredient

Active Ingredient: Titanium Dioxide 11.03%

Inactive Ingredient

Inactive Ingredients: DIISOSTEARYL MALATE, POLYBUTENE, DIMETHICONE, MICA, PHENYL TRIMETHICONE, IRON OXIDE(Cl 77492), CERESIN, COPERNICIA CERIFERA (CARNAUBA) WAX, SORBITAN SESQUIOLEATE, SILICA, OZOKERITE, IRON OXIDE(Cl 77491), CETYL ETHYLHEXANOATE, CETYL PEG/PPG-10/1 DIMETHICONE, IRON OXIDE(Cl 77499), TOCOPHERYL ACETATE, PROPYLPARABEN, PERFUME, BUTYLPARABEN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL

Package Label.principal Display Panel


Structured Label Content

Warnings (WARNINGS)

Warnings: KEEP OUT OF EYES. STOP USING IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

Purpose (PURPOSE)

Purpose: Sunscreen

Description (DESCRIPTION)

ATTENTION: EVITER TOUT CONTACT AVEC LES YEUX. SUSPENDRE L’UTILISATION EN CAS D’IRRITATION. TENIR HORS DE PORTEE DES ENFANTS.

ATENCION: EVITE QUE ENTRE EN LOS OJOS. INTERRUMPA SU USO SI SE PRODUCE IRRITACION. MANTENER FUERA DES ALCANCE DE LOS NINOS.

How to use: APPLY AN ADEQUATE AMOUNT EVENLY OVER ENTIRE FACE.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Titanium Dioxide 11.03%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: DIISOSTEARYL MALATE, POLYBUTENE, DIMETHICONE, MICA, PHENYL TRIMETHICONE, IRON OXIDE(Cl 77492), CERESIN, COPERNICIA CERIFERA (CARNAUBA) WAX, SORBITAN SESQUIOLEATE, SILICA, OZOKERITE, IRON OXIDE(Cl 77491), CETYL ETHYLHEXANOATE, CETYL PEG/PPG-10/1 DIMETHICONE, IRON OXIDE(Cl 77499), TOCOPHERYL ACETATE, PROPYLPARABEN, PERFUME, BUTYLPARABEN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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