THE BODY SHOP POMEGRANATE SPF 15- octinoxate, octisalate, avobenzone lotion 
The Body Shop Wake Forest

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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The Body Shop Pomegranate Moisturizer

Active Ingredients:

Avobenzone (3.0%)

Octinoxate(7.5%)

Octisalate (4.0%)

Sunscreen

Uses  Helps prevent sunburn

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 product is swallowed, get mdeical help or contact a Poison Control Center right away.

 Directions:

  • Apply liberally 15 minutes before sun exposure
  • 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 10 a.m. - 2 p.m.
  •       wear long-sleeved shirts, pants, hats and sunglasses
  •       reapply this product at least every 2 hours
  •       use water resistant sunscreen if swimming or sweating
  • Children under 6 months of age : ask a doctor. 

OTHER INGREDIENTS:  Water, Isododecane, Hydrogenated Polydecene, Glycerin, Arachidyl Alcohol, Glyceryl Stearate, Caprylyl Glycol, Behenyl Alcohol, Benzamidazole Diamond Amidothylcarbamoylpropyl Polymethylsilsesquioxane, Bertholletia Excelsa Seed Oil, Arachidyl Glucoside, Caffeine, Cetyl Alcohol, PEG-100 Searate, Phenoxyethanol, Acrylamide/Ammonium Acrylate Copolymer, Fragrance, Punica Granatum (Pomegranate) Seed Oil, Butylene Glycol, Xanthan Gum, Dimethicone, Polyisobutene, Punica Granatum (Pomegranate) Extract, Disodium EDTA,Sorbic Acid, Adenosine, Polysorbate 20, Sorbitan Isostearate, Pyrus Malus (Apple) Fruit Extract, Hydroxycitronellal, Citronellol, Limonene, Geraniol, Linalool, Alpha-Isomethy lonone, Ursolic Acid

Reports of serious side effects associated with use of the product can be sent to:  THE BODY SHOP 5036 One World Way, Wake Forrest, NC 27587   USA. MADE IS USA  2010 THE BODY SHOP INT'L PLC BN17 6LS, UK  registered trademark of The Body SHop Int'l Plc.  thebodyshop.com

Pomegranate SPF 15

THE BODY SHOP POMEGRANATE  SPF 15
octinoxate, octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-226
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAFFEINE (UNII: 3G6A5W338E)  
ADENOSINE (UNII: K72T3FS567)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
POMEGRANATE (UNII: 56687D1Z4D)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
APPLE JUICE (UNII: 9871T0PD5P)  
URSOLIC ACID (UNII: P3M2575F3F)  
PUNICA GRANATUM SEED (UNII: 7294Z34NS7)  
POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57691-226-0150 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/201206/30/2018
Labeler - The Body Shop Wake Forest (791071279)

Revised: 6/2018
 
The Body Shop Wake Forest