FDA.reportPublic FDA data

Sweet cheeks

Manufacturer
Saje Natural Business Inc.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:33:14

Label at a glance#

ProductSweet cheeks
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps treat and prevent diaper rash. protects chafed skin or minor skin irritations due to diaper rash. seals out wetness.

Dosage and administration

-Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. -Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Storage and handling

-Store at room temperature.

Label contents#

Full prescribing information#

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 or minor skin irritations due to diaper rash. seals out wetness.

Warnings

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

-Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days.

Warnings

OTC - DO NOT USE SECTION

-Do not use if allergic to plants of the marshmallow or asteraceae/compositae/daisy family.

Warnings

OTC - WHEN USING SECTION

-When using this product, avoid contact with the eyes and mucous membranes.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

-Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

-Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

STORAGE AND HANDLING SECTION

-Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Olive oil, beeswax (yellow), butyrospermum parkii (shea) butter, coconut oil, castor oil, aloe barbadensis leaf extract, glycerin, vitamin e, calendula officinalis flower extract, hypericum perforatum flower extract (st john's wort), sunflower oil, rosmarinus officinalis (rosemary) leaf extract, echinacea angustifolia extract, camellia sinensis leaf extract (green tea), althaea officinalis root (marshmallow root), daucus carota sativa (carrot) seed oil, lavender oil

Questions?

REFERENCES SECTION

1-877-275-7253

Principal display panel information

DESCRIPTION SECTION

daily diaper rash ointment
net wt. 75g (2.7 oz) and net wt. 30g (1oz)
daily diaper rash ointment

Sweet cheeks daily diaper rash ointment-Outer label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sweet Cheeks 1oz drug factsSweet Cheeks 1oz drug facts75 g75 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199852zinc oxide 12 % Topical OintmentPSN6
199852zinc oxide 0.12 MG/MG Topical OintmentSCD6
199852ZNO 0.12 MG/MG Topical OintmentSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-021-01Sweet cheeks75 g in 1 JAROINTMENT756
70983-021-01Sweet cheeks1 in 1 BOXOINTMENT16
70983-021-02Sweet cheeks30 g in 1 JAROINTMENT306

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70983-02170983-021-01, 70983-021-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
YELLOW WAX2ZA36H0S2VIACT
CASTOR OILD5340Y2I9GIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
HYPERICUM PERFORATUM FLOWERA6V4CUE7PVIACT
LAVENDER OILZBP1YXW0H8IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
OLIVE OIL6UYK2W1W1EIACT
ZINC OXIDESOI2LOH54ZACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ROSEMARYIJ67X351P9IACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
CARROT SEED OIL595AO13F11IACT

Source Document#

Source XML

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
Sweet cheeksZINC OXIDESaje Natural Business Inc.5fc6486e-8604-5c7b-e053-2991aa0a8d142026-01-13WarningsExact identifier
ndc (package): 70983-021-01
ndc (package): 70983-021-02
ndc (product): 70983-021
ndc11 (package): 70983002101
ndc11 (package): 70983002102
spl id: 48527bf6-00a8-c363-e063-6294a90a5c02
spl set id: 5fc6486e-8604-5c7b-e053-2991aa0a8d14

Reported adverse events (FAERS/openFDA)#

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