VITAMIN E MOISTURE  SPF 15- octinoxate, octisalate, avobenzone lotion 
The Body Shop Wake Forrest

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 Vitamin E Daily Moisturizer

Active Ingredients

Octinoxate (6.0%)                 

Octisalate (4.0%)                  

Avobenzone (3.0%)              

Purpose

Sunscreen

Warnings

For external use only

Do not use

on broken or damaged 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 mecial 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 of 15 or higher and other sun protection measures including:

  • limit time in 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

Inactive Ingredients:

Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Phenyl Trimethicone, Potassium Cetyl Phosphate, Cetyl Dimethicone, Phenoxyethanol, Triethanolamine, Sesamum Indicum (Sesame) Seed Oil,  Tocopheryl Acetate, Fragrance, Carbomer, Behenyl Alcohol, Cetyl Alcohol, Methylparaben, Triticum Vulgare (Wheat) Germ Oil, Citronellol, Tetrasodium EDTA, Butylparaben, Alpha-Isomethyl Ionone, Isobutylparaben, Propylparaben, Linalool, Geraniol, Limonene, Citral, Tocopherol, Eugenol, Famesol, Benxyl Alcohol, Isoeugenol.

Vitamin E Tube

VITAMIN E MOISTURE   SPF 15
octinoxate, octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
TROLAMINE (UNII: 9O3K93S3TK)  
SESAME OIL (UNII: QX10HYY4QV)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DOCOSANOL (UNII: 9G1OE216XY)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57691-098-0150 mL in 1 TUBE; Type 0: Not a Combination Product02/01/200710/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/200710/05/2017
Labeler - The Body Shop Wake Forrest (791071279)

Revised: 10/2017
Document Id: fc91137c-b10d-4534-b094-693ace29106b
Set id: 6ce9d326-a917-461a-ab32-b23c1315258b
Version: 17
Effective Time: 20171007
 
The Body Shop Wake Forrest