FOUNDATION CARAMEL- titanium dioxide, octinoxate, zinc oxide liquid
J2D INTERNATIONAL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - J2D INTERNATIONAL (689515247)

Registrant - J2D INTERNATIONAL (689515247)

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