SANDAWHA MOISTURIZING BABY- glycerin cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

glycerin

INACTIVE INGREDIENT

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

PURPOSE

suitable for delicate baby's skin

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 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72289-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	3.1545 g  in 100 g

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: 72289-0006-1	75 g 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(72289-0006) , manufacture(72289-0006)