SKIN CARE PRESCRIPTION - avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotion 
Skin Care Physicians, 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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Drug Facts

Active Ingredients:                                                                                                   Purpose
Avobenzone 3.0%...................................................................................................Sunscreen (A)
Octocrylene  4.0%...................................................................................................Sunscreen (B)
Oxybenzone 6.0%...................................................................................................Suncreeen (A)
Homosalate  15.0%.................................................................................................Sunscreen (B)
Octisalate     5.0%...................................................................................................Sunscreen (B)


Uses

Warnings

For External use only
UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.

Directions

Inactive Ingredients

Aqua; Acrylates/C10-30 Alkyl Acrylate Crosspolymer; Sorbitol; Marshmellow Extract,; Ivy Extract; Cucumber Extract; Elder Flower; Arnica Extract; EDTA; Aloe Barbadensis Leaf Juice; Isopropyl Palmitate; Stearic Acid; PEG100 Stearate; Dimethicone; Tocopheryl Acetate; Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; DMDM Hydantoim; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Acrylates/C12-22 Alkylmethacrylates Copolymer; Retinyl Palmitate

image of tube label


When using this product keep out of eyes.

Rinse with water to remove.

May stain some fabrics

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

Stop use and ask a doctor if skin rash occurs.

SKIN CARE PRESCRIPTION 
avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52347-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3.40 g  in 114.4 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate17.01 g  in 113.4 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 113.4 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 113.4 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4.54 g  in 113.4 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Dimethicone (UNII: 92RU3N3Y1O)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
ACAI (UNII: 46AM2VJ0AW)  
CRANBERRY (UNII: 0MVO31Q3QS)  
CUCUMBER (UNII: YY7C30VXJT)  
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
ARNICA MONTANA (UNII: O80TY208ZW)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
EDETIC ACID (UNII: 9G34HU7RV0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52347-111-01116 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/23/2010
Labeler - Skin Care Physicians, Inc. (064598985)

Revised: 10/2010
Document Id: 4d08bcae-5846-41a6-8136-651da8e1c582
Set id: 8b31ca87-c814-478e-909d-31332233f74d
Version: 2
Effective Time: 20101018
 
Skin Care Physicians, Inc.