FDA.reportPublic FDA data

Super Sensitive™ Diaper Rash Cream

Manufacturer
ORGANIC & SUSTAINABLE BEAUTY
Effective date
2015-09-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:43:30

Label at a glance#

ProductSuper Sensitive Diaper Rash
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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, 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIF♥RNIA BABY®
trusted since 1995

IMPROVED

super sensitive™

DIAPER RASH
CREAM
SKIN PROTECTANT

FREE OF SCENT & SCENT MASKING AGENTS
ZINC OXIDE • HELPS TO PREVENT & RELIEVE
ULTRA-PURIFIED LANOLIN • CONCENTRATED
NO GLUTEN, SOY, OAT OR DAIRY

NO ADDED FRAGRANCE
CLOTH DIAPER SAFE

ALLERGY
TESTED

• for babies • kids •
• sensitive adults •

Net Wt. 82 g/2.9 Oz.

Principal Display Panel - 82 g Tube Label
Principal Display Panel - 82 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417994zinc oxide 12 % Topical CreamPSN2
417994zinc oxide 120 MG/ML Topical CreamSCD2
417994zinc oxide 12 % Topical CreamSY2
417994ZNO 120 MG/ML Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52915-110-292020-01-31C16284748780-19d75b9d0-2155-f424-e053-dadaa90a57ceSuper Sensitive™ Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-110-29Super Sensitive Diaper Rash82 g in 1 TUBECREAM822

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-110SUPER SENSITIVE DIAPER RASH (ZINC OXIDE) CREAM [ORGANIC & SUSTAINABLE BEAUTY]2Legacy NDC, 1 package rows20150903_f5cb3794-1f8e-4440-a002-f242b4e09413.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
allantoinINACTIVE INGREDIENT344S277G0Z2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X2
calendula officinalis flowerINACTIVE INGREDIENTP0M7O4Y7YD2
carthamus tinctorius seed oleosomesINACTIVE INGREDIENT9S60Q723092
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S2
cetyl alcoholINACTIVE INGREDIENT936JST6JCN2
coconut oilINACTIVE INGREDIENTQ9L0O73W7L2
evening primrose oilINACTIVE INGREDIENT3Q9L08K71N2
fytic acidINACTIVE INGREDIENT7IGF0S7R8I2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
glyceryl caprylateINACTIVE INGREDIENTTM2TZD4G4A2
glyceryl stearate SEINACTIVE INGREDIENTFCZ5MH785I2
lanolinINACTIVE INGREDIENT7EV65EAW6H2
levulinic acidINACTIVE INGREDIENTRYX5QG61EI2
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7U2
p-anisic acidINACTIVE INGREDIENT4SB6Y7DMM32
squalaneINACTIVE INGREDIENTGW89575KF92
stearyl glycyrrhetinateINACTIVE INGREDIENT3YYE6VJS0P2
viola tricolorINACTIVE INGREDIENT9Q24RAI43V2
WaterINACTIVE INGREDIENT059QF0KO0R2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2
yucca schidigera rootINACTIVE INGREDIENTE2H9ET15AT2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52915-11052915-110-29

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
Water059QF0KO0RIACT
glyceryl stearate SEFCZ5MH785IIACT
cetostearyl alcohol2DMT128M1SIACT
glyceryl caprylateTM2TZD4G4AIACT
lanolin7EV65EAW6HIACT
calendula officinalis flowerP0M7O4Y7YDIACT
viola tricolor9Q24RAI43VIACT
coconut oilQ9L0O73W7LIACT
medium-chain triglyceridesC9H2L21V7UIACT
glycerinPDC6A3C0OXIACT
cetyl alcohol936JST6JCNIACT
levulinic acidRYX5QG61EIIACT
squalaneGW89575KF9IACT
carthamus tinctorius seed oleosomes9S60Q72309IACT
p-anisic acid4SB6Y7DMM3IACT
allantoin344S277G0ZIACT
xanthan gumTTV12P4NEEIACT
evening primrose oil3Q9L08K71NIACT
fytic acid7IGF0S7R8IIACT
yucca schidigera rootE2H9ET15ATIACT
aloe vera leafZY81Z83H0XIACT
stearyl glycyrrhetinate3YYE6VJS0PIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 178 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
lanolinLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ATABLET / ORAL1 mgExact identifier — unii candidate
2 equally ranked IID candidates
lanolinLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
glyceryl stearate SEGLYCERYL STEARATE SEFCZ5MH785ILOTION / TOPICAL46 mgExact identifier — unii candidate
2 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
squalaneSQUALANEGW89575KF9POWDER / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii candidate
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
glyceryl stearate SEGLYCERYL STEARATE SEFCZ5MH785ICREAM / TOPICAL4 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0827b7e6-6b2c-4b79-8f69-1f6a4c2cec61f5cb3794-1f8e-4440-a002-f242b4e094132015-09-02WarningsExact identifier
spl id: 0827b7e6-6b2c-4b79-8f69-1f6a4c2cec61
spl set id: f5cb3794-1f8e-4440-a002-f242b4e09413

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.