Mens Maca Root Energising Face Protector SPF15

Dosage form: lotion
Ingredients: OCTINOXATE 5g in 100mL, AVOBENZONE 3g in 100mL, OCTISALATE 3g in 100mL
Labeler: The Body Shop Wake Forest
NDC Code: 57691-001

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.

Active Ingredients                        

Octinoxate (5.0%)                                  

Avobenzone(3.0%)                                 

Octisalate (3.0%)                                   

Purpose          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 and ask a doctor if

  • rash occurs

Keep out of reach of children

If prduct 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 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 of age: ask a doctor

Inactive ingredients:

Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Aloe Barbadensis Gel,

Diethylhexyl Carbonate, Sorbitol, Caprylyl Glycol, Cyclopentasiloxane, Magnesium Aluminum Silicate, Potassium Cetyl Phosphate, Bertholletia Excelsa (Brazil) Nut Oil, Cetearyl Alcohol, Dimethicone, Fragrance, Creatine, Xanthan Gum, Tetrasodium EDTA, Hydrolized Lepidium Meyenii Root, 1,2-hexanediol, Citric Acid, Caprylyl Glycine, Sodium Hydroxide

820294 Ref: 57207   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 IN USA  2008 THE BODY SHOP INT'L PLC. BN176LS UK. thebodyshop.com

MENS MACA ROOT ENERGISING FACE PROTECTOR   SPF15
octinoxate avobenzone octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL MONOSTEARATE 
GLYCERIN 
1,3-BUTYLENE GLYCOL 
SORBITOL 
MAGNESIUM ALUMINUM SILICATE 
CYCLOMETHICONE 5 
CETOSTEARYL ALCOHOL 
BRAZIL NUT 
CREATINE 
XANTHAN GUM 
EDETATE SODIUM 
ALOE VERA LEAF 
SODIUM HYDROXIDE 
CITRIC ACID MONOHYDRATE 
ALKYL (C12-15) BENZOATE 
CAPRYLYL GLYCOL 
POTASSIUM CETYL PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:57691-001-0150 mL in 1 TUBE
2NDC:57691-001-02100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2008
Labeler - The Body Shop Wake Forest (791071279)

Revised: 06/2014
 
The Body Shop Wake Forest

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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