Sara Lee Philippines, Inc.

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

DANGEROUS

The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).