PONDS LUMINOUS FINISH BB CREAM MEDIUM SPF 15- octinoxate, zinc oxide lotion

Ponds by

Drug Labeling and Warnings

Ponds by is a Otc medication manufactured, distributed, or labeled by CONOPCO Inc. d/b/a Unilever, Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Octinoxate 7.49%, Zinc Oxide 5.12%

PURPOSE

Purpose
Sunscreen

INDICATIONS & USAGE

Uses

· helps prevent sunburn
· if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

Warnings

· For external use only

· Do not use on damaged or broken skin

· When using this product keep out of eyes.  Rinse with water to remove.

· Stop use and ask a doctor if rash occurs

· Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

· apply liberally and evenly 15 minutes before sun exposure
· children under 6 months of age: Ask a doctor
· reapply at least every 2 hours
· use a water resistant sunscreen if swimming or sweating
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
· limit time in the sun, especially from 10a.m. - 2p.m.
· wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients

Water (Agua), Cyclopentasiloxane, Glycerin, Niacinamide, Dimethicone Crosspolymer, Potassium Chloride, PEG-10 Dimethicone, Titanium Dioxide, Dicaprylyl Carbonate, Disteardimonium Hectorite, Magnesium Sulfate, Stearic Acid, Cholesterol, Bisabolol, Allantoin, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Tocopheryl Acetate, Fragrance (Fragancia), DMDM Hydantoin, Sucrose Distearate, Alumina, Disodium EDTA, Dimethicone, Iodopropynyl Butylcarbamate, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).

QUESTIONS

Questions or comments?
Call toll free 1-800-909-9493

PDP

1.5 fl oz Carton

INGREDIENTS AND APPEARANCE

PONDS  LUMINOUS FINISH BB CREAM MEDIUM SPF 15
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1284
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.49 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALLANTOIN (UNII: 344S277G0Z)
GINGER (UNII: C5529G5JPQ)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CHOLESTEROL (UNII: 97C5T2UQ7J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM SULFATE (UNII: DE08037SAB)
STEARIC ACID (UNII: 4ELV7Z65AP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SUCROSE DISTEARATE (UNII: 33X4X4B90S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE (UNII: 92RU3N3Y1O)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1284-2	1 in 1 CARTON
1	NDC: 64942-1284-1	44 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/17/2013

Labeler - CONOPCO Inc. d/b/a Unilever (001375088)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	manufacture(64942-1284)