MENS MACA ROOT ENERGISING FACE PROTECTOR SPF15- octinoxate avobenzone octisalate 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 Men's Maca Root Day Moist

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

MacaRootSPF15

MENS MACA ROOT ENERGISING FACE PROTECTOR SPF15
octinoxate avobenzone octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57691-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITOL (UNII: 506T60A25R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BRAZIL NUT (UNII: XKR79OET1K)
CREATINE (UNII: MU72812GK0)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57691-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2008	10/05/2017
2	NDC:57691-001-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2008	10/05/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2008	10/05/2017

Labeler - The Body Shop Wake Forest (791071279)

Revised: 10/2017

Document Id: 44bde8ef-42e1-405a-85ae-ffe113f3b023

Set id: a1860cf4-b044-4c7e-b32d-bfcecc0e67e3

Version: 19

Effective Time: 20171005

The Body Shop Wake Forest