FOUNDATION CARAMEL- titanium dioxide, octinoxate, zinc oxide liquid

FOUNDATION CARAMEL by

Drug Labeling and Warnings

FOUNDATION CARAMEL by is a Otc medication manufactured, distributed, or labeled by J2D INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURPOSE

Purpose: Sunscreen

WARNINGS

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOUNDATION CARAMEL 
titanium dioxide, octinoxate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69958-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.90 g  in 37 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.85 g  in 37 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.37 g  in 37 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69958-030-01	37 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2015

Labeler - J2D INTERNATIONAL (689515247)

Registrant - J2D INTERNATIONAL (689515247)

Establishment
Name	Address	ID/FEI	Business Operations
J2D INTERNATIONAL		689515247	manufacture(69958-030)