PCA SKIN BODY HYDRATOR SPF30- zinc oxide and octinoxate lotion

PCA SKIN Body Hydrator by

Drug Labeling and Warnings

PCA SKIN Body Hydrator by is a Otc medication manufactured, distributed, or labeled by Physicians Care Alliance, LLC DBA PCA SKIN. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

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Active Ingredient:         Purpose:

Zinc Oxide(9.8%)         Sunscreen (UVA UVB)

Octinoxate(7.5%)         Sunscreen (UVB)

INDICATIONS & USAGE

Uses:  Provides high protection against sunburn.

WARNINGS

Warnings: For external use only. Keep out of eyes. Rinse with water to remove.  Stop use and consult a physician ifskin rash and irritation develops and lasts.

DOSAGE & ADMINISTRATION

Directions:For use by adults and children six months and older.  apply liberally to exposed areas at least 30 minutes prior to sun exposure.  Reapply every two hours or as needed after swimming or perspiring.  Consult a physician prior to use on children under six months of age.

Other Information:  Sun Alert. Limiting sun exposure, wearing protecting clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

INACTIVE INGREDIENT

Inactive Ingredients:Water/Aqua/Eau, Ethylhexyl Palmitate, GLycerin, Cyclopentasiloxane, Isononyl Isononanoate, Cetearyl Alcohol, SD Alcohol 40-B, Polyacrylate-13, Dimethicone, Tocopheryl Acetate, Triethoxycaprylylsilane, Lactic Acid, Kojic Acid, Butylene Glycol, Morus Alba Root Extract, Arctostaphylos, Uva Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Caffeine, Silybum Marianum Extract, Arginine, Microcrystalline Cellulose, C20-22 Allcohols, Polyisobutene, Cetearyl Glucoside, Caprylyl Glycol, Cellulose Gum, Aloe Barbadensis Leaf Juice, Sodium PCA, Sodium Hyaluronate, Magnesium Ascorbyl Phosphate, Tetrasodium EDTA, Cirtus Grandis (Grapefruit) Peel oil, Ethylhexylglycerin, Phenoxyethanol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCA SKIN BODY HYDRATOR  SPF30
zinc oxide and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-167
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.8 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAFFEINE (UNII: 3G6A5W338E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MORUS ALBA ROOT BARK (UNII: SV6B76DK9N)
LACTIC ACID (UNII: 33X04XA5AT)
ARGININE (UNII: 94ZLA3W45F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
ALCOHOL (UNII: 3K9958V90M)
MILK THISTLE (UNII: U946SH95EE)
KOJIC ACID (UNII: 6K23F1TT52)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-167-05	1 in 1 CARTON	10/01/2010
1	NDC: 68726-167-01	198.4 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68726-167-02	48 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2010
3	NDC: 68726-167-04	1 in 1 CARTON	10/01/2010
3	NDC: 68726-167-03	9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2010

Labeler - Physicians Care Alliance, LLC DBA PCA SKIN (969945133)