SANDAWHA MOISTURIZING BABY- glycerin lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

glycerin

INACTIVE INGREDIENT

Water(Aqua)
Caprylic/Capric Triglyceride
Glycerin
Camellia Japonica Seed Oil
Hydrogenated Palm Kernel Oil
Pentylene Glycol
Propanediol
Phosphatidylcholine
Phytosteryl Macadamiate
Panthenol
Camellia Sinensis Leaf Extract
Chamomilla Recutita (Matricaria) Leaf Extract
Thujopsis Dolabrata Branch Extract
Butyrospermum Parkii (Shea) Butter
Mangifera Indica (Mango) Seed Butter
Xanthan Gum
Sorbitan Caprylate
Glycyrrhiza Glabra (Licorice) Root Extract
Arginine
Betaine
Magnolia Kobus Bark Extract
Salix Alba (Willow) Bark Extract
Olea Europaea (Olive) Fruit Oil
Centella Asiatica Extract
Squalane
Tocopherol
Opuntia Ficus-Indica Fruit Extract
Dipotassium Glycyrrhizate
Trehalose
Aloe Barbadensis Leaf Extract
Dimethyl Sulfone
Polygonum Cuspidatum Root Extract
Scutellaria Baicalensis Root Extract
Citrus Unshiu Peel Extract
Rosmarinus Officinalis (Rosemary) Leaf Extract
Bisabolol
Hyaluronic Acid
Rosa Canina Fruit Oil
Vitis Vinifera (Grape) Skin Extract
Stearyl Glycyrrhetinate
Bioflavonoids
Houttuynia Cordata Extract
Linoleic Acid
Portulaca Oleracea Extract
Pyrus Malus (Apple) Fruit Extract
Silybum Marianum Extract
Vaccinium Angustifolium (Blueberry) Fruit Extract
Panax Ginseng Root Extract
Levulinic Acid
Ginkgo Biloba Leaf Extract
Morus Alba Bark Extract
Rubus Idaeus (Raspberry) Fruit Extract
Brassica Oleracea Italica (Broccoli) Extract
Glycine Soja (Soybean) Seed Extract
Pueraria Lobata Root Extract
Rutin
Astaxanthin
Quercetin
Aniba Rosodora (Rosewood) Wood Oil
Jasminum Sambac (Jasmine) Flower Extract
Lavandula Angustifolia (Lavender) Oil
Rosmarinus Officinalis (Rosemary) Leaf Oil

PURPOSE

soothes and protects sensitive skin

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Gently massage into skin as often as needed

WARNINGS

for external use only

do not use if sensitive to any of the ingredients

discontinue use if signs of irritation or rash appear

if irritation or rash persists, contact a doctor

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANDAWHA MOISTURIZING BABY 
glycerin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72289-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	4.305 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
SQUALENE (UNII: 7QWM220FJH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72289-0005-1	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	02/24/2019

Labeler - SKINCURE INC (557830240)

Registrant - SKINCURE INC (557830240)

Establishment
Name	Address	ID/FEI	Business Operations
SKINCURE INC		557830240	label(72289-0005) , manufacture(72289-0005)