ALOE SOOTHING MOISTURE SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion 
Buth-Na-Bodhaige, Inc.,

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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Aloe Soothing Moisture Lotion SPF 15

Drug Facts

Active Ingredients Purpose
Avobenzone (3.0% w/w) Sunscreen
Octinoxate (2.9% w/w) Sunscreen
Octisalate (5.0% w/w) Sunscreen
Octocrylene (2.2% w/w) Sunscreen

Uses

Warnings

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 medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Sesamum Indicum (Sesame) Seed Oil, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Panthenol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Carbomer, Bisabolol, Potassium Sorbate, Tetrasodium EDTA, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, BHT, Avena Sativa (Oat) Kernel Extract, Citric Acid.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Label

THE
BODY
SHOP

THE BODY SHOP
ALOE

SOOTHING MOISTURE LOTION

BROAD SPECTRUM SPF 15 SUNSCREEN

FRAGRANCE-FREE, COLOURANT-FREE,
PARABEN-FREE, ALCOHOL-FREE
WITH PURE, HAND-FILLETED ALOE FROM CAMPECHE, MEXICO

50 ml (1.69 US FL OZ)

FORMULATED FOR
SENSITIVE SKIN

PRINCIPAL DISPLAY PANEL - 50 ml Tube Label
ALOE SOOTHING MOISTURE SPF 15 
octisalate, avobenzone, octinoxate, and octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57691-889
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.029 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.022 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Sorbitol (UNII: 506T60A25R)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
SESAME OIL (UNII: QX10HYY4QV)  
Dimethicone (UNII: 92RU3N3Y1O)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Panthenol (UNII: WV9CM0O67Z)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Xanthan Gum (UNII: TTV12P4NEE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
LEVOMENOL (UNII: 24WE03BX2T)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Pentylene Glycol (UNII: 50C1307PZG)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
OAT (UNII: Z6J799EAJK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57691-889-50 50 mL in 1 TUBE; Type 0: Not a Combination Product 04/11/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/11/2016
Labeler - Buth-Na-Bodhaige, Inc., (791071279)

Revised: 10/2016
Document Id: 1440375b-7c88-42f6-876d-e23640526f62
Set id: f34b1295-43ad-408d-98a6-f123462dac21
Version: 2
Effective Time: 20161010
 
Buth-Na-Bodhaige, Inc.,