CALMING DIAPER RASH- zinc oxide cream

CALMING DIAPER RASH by

Drug Labeling and Warnings

CALMING DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by ORGANIC & SUSTAINABLE BEAUTY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 12%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash
• helps seal out wetness

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if condition worsens. If symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• apply an even layer for everyday protection and when a rash is present

Other information

• protect the product in this container from excessive heat and direct sunlight
• report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

Inactive ingredients

Water, glyceryl stearate, cetearyl alcohol, glyceryl caprylate, lanolin, calendula officinalis flower extract, viola tricolor extract, cocos nucifera (coconut) oil, caprylic/capric triglyceride, glycerin, cetyl alcohol, levulinic acid, squalane, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, melaleuca alternifolia (tea tree) leaf oil, carthamus tinctorius (safflower) oleosomes, p-anisic acid, allantoin, xanthan gum, oenothera biennis (evening primrose) oil, phytic acid, yucca schidigera root extract, aloe barbadensis leaf juice, stearyl glycyrrhetinate.

PRINCIPAL DISPLAY PANEL - 82 g Tube Label

CALIF♥RNIA BABY®
trusted since 1995

IMPROVED

calming™

DIAPER RASH
CREAM
SKIN PROTECTANT

FRENCH LAVENDER ZINC OXIDE
HELPS TO PREVENT & RELIEVE
ULTRA-PURIFIED LANOLIN CONCENTRATED
NO GLUTEN, SOY, OAT OR DAIRY

PURE ESSENTIAL OILS
CLOTH DIAPER SAFE

ALLERGY
TESTED

for babies kids
sensitive adults

Net Wt. 82 g/2.9 Oz.

INGREDIENTS AND APPEARANCE

CALMING DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52915-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
glyceryl stearate SE (UNII: FCZ5MH785I)
cetostearyl alcohol (UNII: 2DMT128M1S)
glyceryl caprylate (UNII: TM2TZD4G4A)
lanolin (UNII: 7EV65EAW6H)
calendula officinalis flower (UNII: P0M7O4Y7YD)
viola tricolor (UNII: 9Q24RAI43V)
coconut oil (UNII: Q9L0O73W7L)
medium-chain triglycerides (UNII: C9H2L21V7U)
glycerin (UNII: PDC6A3C0OX)
cetyl alcohol (UNII: 936JST6JCN)
levulinic acid (UNII: RYX5QG61EI)
squalane (UNII: GW89575KF9)
lavender oil (UNII: ZBP1YXW0H8)
clary sage oil (UNII: 87L0D4U3M0)
tea tree oil (UNII: VIF565UC2G)
carthamus tinctorius seed oleosomes (UNII: 9S60Q72309)
p-anisic acid (UNII: 4SB6Y7DMM3)
allantoin (UNII: 344S277G0Z)
xanthan gum (UNII: TTV12P4NEE)
evening primrose oil (UNII: 3Q9L08K71N)
fytic acid (UNII: 7IGF0S7R8I)
yucca schidigera root (UNII: E2H9ET15AT)
aloe vera leaf (UNII: ZY81Z83H0X)
stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52915-100-29	82 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)