ALOE SOOTHING MOISTURE SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion

Aloe Soothing Moisture SPF 15 by

Drug Labeling and Warnings

Aloe Soothing Moisture SPF 15 by is a Otc medication manufactured, distributed, or labeled by Buth-Na-Bodhaige, Inc.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

• 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 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 a water resistant sunscreen if swimming or sweating.
• children under 6 months of age: ask a doctor.

Other information

• protect the product in this container from excessive heat and direct sun.

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 SUNSCREEN SPF 15

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

INGREDIENTS AND APPEARANCE

ALOE SOOTHING MOISTURE SPF 15 
octisalate, avobenzone, octinoxate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-921
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: 57691-921-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	11/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/11/2018

Labeler - Buth-Na-Bodhaige, Inc., (791071279)