ALOE SOOTHING MOISTURE  SPF 15- octinoxate, octocrylene and 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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Drug Facts

Active Ingredients

Octinoxate (7.0%)                      

Octocrylene (6.0%)                    

Avobenzone (3.0%)                 

Purpose

Sunscreen

Warnings


For external use only

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 medical 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 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: ask a doctor

Inactive Ingredients:  

Ale Barbadensis Gel, Glycerin, Butylene Glycol, Cyclomethicone, Sorbitol, Glyceryl Stearate Citrate, Cetearyl Alcohol, Caprylyl Glycol, Myristyl Myristate, Sesamum Indicum (sesame) Seed Oil, Butyrospermum Parkii (Shea Butter), Panthenol, Carbomer, Xanthan Gum, Bisabolol, Disodium EDTA, Pentylene Glycol, Avena Sativa (Oat) Bran Extract, Sodium Hydroxide, Water


Reports of serious side effects associated with use of the product can be sent to:   THE BODY SHOP 5036 One World Way, Wake Forest, NC 27587 USA.  Made in USA.

TBS Aloe SPF 15 Tube

ALOE SOOTHING MOISTURE   SPF 15
octinoxate, octocrylene, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57691-096
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE6 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
GLYCERIN 
SORBITOL 
CYCLOMETHICONE 
1,3-BUTYLENE GLYCOL 
CETOSTEARYL ALCOHOL 
SESAME OIL 
SHEA BUTTER 
AVENA SATIVA POLLEN 
PANTHENOL 
XANTHAN GUM 
LEVOMENOL 
EDETATE DISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57691-096-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2006
Labeler - The Body Shop Wake Forest (791071279)

Revised: 6/2013
 
The Body Shop Wake Forest