PCA SKIN BODY HYDRATOR SPF30- zinc oxide and octinoxate lotion 
CP SKIN Health Group, 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.

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Perfecting Protection SPF 30

DRUG FACTS

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Active Ingredient:         Purpose:

Zinc Oxide(9.8%)         Sunscreen (UVA UVB)

Octinoxate(7.5%)         Sunscreen (UVB)

Uses:  Provides high protection against sunburn.

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.

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 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.

PerfectingSPFUC

PCA SKIN BODY HYDRATOR  SPF30
zinc oxide and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-167
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.8 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68726-167-051 in 1 CARTON10/01/201004/30/2023
1NDC:68726-167-01198.4 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68726-167-0248 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/201004/30/2023
3NDC:68726-167-041 in 1 CARTON10/01/201004/30/2023
3NDC:68726-167-039 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/201004/30/2023
Labeler - CP SKIN Health Group, Inc (611921669)

Revised: 6/2023
 
CP SKIN Health Group, Inc