Keep The Peace Protect and Correct: Package Insert and Label Information

KEEP THE PEACE PROTECT AND CORRECT — titanium dioxide and zinc oxide cream
Philosophy, Inc.

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.

TITANIUM DIOXIDE……4.8%

ZINC OXIDE……….3.0%

CYCLOPENTASILOXANE, DIMETHICONE CROSSPOLYMER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BEHENOXY DIMETHICONE, PHYTOSTEROLS, TOCOTRIENOLS, TOCOPHEROL, ORYZA SATIVA (RICE) BRAN WAX, SQUALENE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, GLYCINE SOJA (SOYBEAN) STEROLS, DIMETHICONE, CETEARYL METHICONE, LINOLEIC ACID, PHOSPHOLIPIDS, POLYHYDROXYSTEARIC ACID, BISABOLOL, CAPYLYL GLYCOL, SIMETHICONE, ALUMINA, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77491, 77492, 77499).

Sunscreen

Uses: helps prevent suburn

higher SPF gives more sunburn protection

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT.

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE

STOP USE AND ASK DOCTOR IF A RASH OR IRRITATION DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

QUESTIONS? CALL — 1-800-568-3515

KEEP THE PEACE PROTECT AND CORRECT titanium dioxide and zinc oxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-6600 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.88 mL in 60 mL ZINC OXIDE (ZINC CATION) ZINC OXIDE 1.8 mL in 60 mL

Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 DIMETHICONE ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES ALPHA-TOCOPHEROL RICE BRAN SQUALENE ENGLISH LAVENDER OIL SOYBEAN DIMETHICONE LINOLEIC ACID EGG PHOSPHOLIPIDS LEVOMENOL CAPRYLYL GLYCOL ALUMINUM OXIDE PHENOXYETHANOL OCTYLTRIETHOXYSILANE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50184-6600-1 60 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/24/2011

Labeler — Philosophy, Inc. (948102256)

Establishment
Name	Address	ID/FEI	Operations
Philosophy Inc for BioTech Research Labs		948102256	manufacture

Revised: 01/2011 Philosophy, Inc.