PERFECT SKIN PACT CARAMEL- titanium dioxide powder
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 17.17%

INACTIVE INGREDIENT

Inactive Ingredients: TALC, ZEA MAYS (CORN) STARCH, POLYGLYCERYL-2 TRIISOSTEARATE, SILICA, MICA, IRON OXIDE(Cl 77492), DIMETHICONE, MINERAL OIL, IRON OXIDE(Cl 77491), IRON OXIDE(Cl 77499), MAGNESIUM MYRISTATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TOCOPHERYL ACETATE, PERFUME, PROPYLPARABEN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, BUTYLPARABEN

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

PERFECT SKIN PACT CARAMEL
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69958-110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.06 g in 12 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69958-110-01	12 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(69958-110)