Calming Diaper Rash (Zinc Oxide) Cream [Organic & Sustainable Beauty] -

CALMING DIAPER RASH (ZINC OXIDE) CREAM [ORGANIC & SUSTAINABLE BEAUTY]
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NDC	52915-100-29
Set ID	27db0117-fde2-4814-8f6d-a6a07e525c42
Category	HUMAN OTC DRUG LABEL
Packager	ORGANIC & SUSTAINABLE BEAUTY
Generic Name
Product Class
Product Number
Application Number	PART347

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)

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Medic

CALMING DIAPER RASH (ZINC OXIDE) CREAM [ORGANIC & SUSTAINABLE BEAUTY]

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