SUPER SENSITIVE DIAPER RASH- zinc oxide cream

SUPER SENSITIVE DIAPER RASH by

Drug Labeling and Warnings

SUPER SENSITIVE 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

Glyceryl starch, caprylic/capric triglyceride, lanolin, glyceryl stearate, cetearyl alcohol, glyceryl caprylate, cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, stearyl glycyrrhetinate (licorice).

PRINCIPAL DISPLAY PANEL - 82 g Tube Label

CALIF♥RNIA BABY®

TRUSTED
SINCE 1995

therapeutic relief™

SUPER SENSITIVE™
DIAPER RASH
OINTMENT
SKIN PROTECTANT

PRESERVATIVE FREE

USDA Certified Biobased
Product 100%

TREATS, PREVENTS & PROTECTS
NO ADDED FRAGRANCE

BABIES + KIDS + ADULTS

ALLERGY
TESTED

© 2019

NET WT 82 g/2.9 oz.

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%

INGREDIENTS AND APPEARANCE

SUPER SENSITIVE DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52915-140
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
DIMETHYLIMIDAZOLIDINONE RICE STARCH (UNII: 43YT4X3R70)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
lanolin (UNII: 7EV65EAW6H)
glyceryl stearate SE (UNII: FCZ5MH785I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52915-140-29	82 g in 1 TUBE; Type 0: Not a Combination Product	08/31/2015
2	NDC: 52915-140-05	14 g in 1 TUBE; Type 0: Not a Combination Product	08/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/31/2015

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)