SPL v1
SPL
SPL Set ID 5ed7d541-6b57-422a-882a-669f905eca1f
Route
TOPICAL
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.90 g) Octinoxate (1.85 g) Zinc Cation (0.37 g)
Inactive Ingredients
Water Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-06-01

Description

Active Ingredient: TITANIUM DIOXIDE 7.84%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, ZINC OXIDE 1.02%

Purpose

Purpose: Sunscreen


Medication Information

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.

Warnings

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

Active Ingredient

Active Ingredient: TITANIUM DIOXIDE 7.84%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, ZINC OXIDE 1.02%

Inactive Ingredient

Inactive Ingredients: WATER, MINERAL OIL, OCTYLDODECANOL, CETYL ETHYLHEXANOATE, GLYCERIN, DIMETHICONE, MICA, CETYL PEG/PPG-10/1 DIMETHICONE, IRON OXIDE(Cl 77492), BEESWAX, ISOAMYL p-METHOXYCINNAMATE, SORBITAN SESQUIOLEATE, IRON OXIDE(Cl 77491), SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM CHLORIDE, IRON OXIDE(Cl 77499), DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, PERFUME, ALLANTOIN, MORUS ALBA BARK EXTRACT, PORTULACA OLERACEA EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, DISODIUM EDTA

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

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

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 7.84%, ETHYLHEXYL METHOXYCINNAMATE 5.00%, ZINC OXIDE 1.02%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: WATER, MINERAL OIL, OCTYLDODECANOL, CETYL ETHYLHEXANOATE, GLYCERIN, DIMETHICONE, MICA, CETYL PEG/PPG-10/1 DIMETHICONE, IRON OXIDE(Cl 77492), BEESWAX, ISOAMYL p-METHOXYCINNAMATE, SORBITAN SESQUIOLEATE, IRON OXIDE(Cl 77491), SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM CHLORIDE, IRON OXIDE(Cl 77499), DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, PERFUME, ALLANTOIN, MORUS ALBA BARK EXTRACT, PORTULACA OLERACEA EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, DISODIUM EDTA

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


Advanced Ingredient Data


Raw Label Data

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