FDA.reportPublic FDA data

CC Cream SPF 30

Manufacturer
HAN Skin Care Cosmetics, LLC | Columbia Cosmetics Manufacturing, Inc.
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:28

Label at a glance#

ProductCC Cream SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply daily, alone or under makeup. Apply liberally 15 minutes before sun exposure and as needed. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing. Use water resistant sunscreen if swimming or sweating. Sun Protecion Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectum S...

Label contents#

Full prescribing information#

Active Ingredients(in each 30 ml)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21%

Titanium Dioxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

warnings

WARNINGS SECTION

  • For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control center or get medical help right  away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply daily, alone or under makeup.
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing.
  • Use water resistant sunscreen if swimming or sweating.
  • Sun Protecion Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectum SPF of 15 or higher and other sun protection measure including: limiting time in the sun, especially from 10am-2pm; wearing long sleeve shirts, pants and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Coconut Alkanes, Cocos Nucifera (Virgin Coconut) Oil, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Ricinus Communis (Castor) Seed Oil*, Ethyl Macadamiate, Shea Butter Ethyl Ester, Glycerin*, Polyglyceryl Esters, Polyhydroxystearic Acid, Citrus Aurantium Dulcis (Orange) Peel Wax, Simmondsia Chinensis (Jojoba) Seed Oil*, Jojoba Esters, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter) Fruit*, Tocopherol (Vitamin E), Capric Acid, Silica, Disteardimonium Hectorite, Kaolin, Argania Spinosa (Argan) Kernel Oil, Rosa Canina Seed (Rosehip) Oil, Lavandula Angustifolia (Lavender) Oil, Olea Europaea (Olive) Oil, Origanum Vulgare (Oregano) Leaf Extract,
Tocopheryl Acetate, Basabolol, Malic Acid. May Contain: Iron Oxides.
*Certified Organic

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79489-0010-02023-01-30C16284748780-1f386c649-b180-0266-e053-dadaa90a7c1aCC Cream SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79489-0010-0CC Cream SPF 301 in 1 BOXCREAM12
79489-0010-0CC Cream SPF 3030 mL in 1 BOTTLE, PUMPCREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79489-0010CC CREAM SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [HAN SKIN CARE COSMETICS, LLC]2Legacy NDC, 2 package rows20211028_0fa941ca-44a9-440f-b6bd-ab7ecf85bfaf.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79489-001079489-0010-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT ALKANES1E5KJY107TIACT
COCONUT OILQ9L0O73W7LIACT
TRICAPRILIN6P92858988IACT
ALOE VERA LEAFZY81Z83H0XIACT
CASTOR OILD5340Y2I9GIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
GLYCERINPDC6A3C0OXIACT
ORANGE PEEL WAX0U715N387CIACT
JOJOBA OIL724GKU717MIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
CARNAUBA WAXR12CBM0EIZIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
CAPRIC ACID4G9EDB6V73IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
KAOLIN24H4NWX5COIACT
ARGAN OIL4V59G5UW9XIACT
ROSA MOSCHATA OILJ99W255AWFIACT
LAVENDER OILZBP1YXW0H8IACT
OLIVE OIL6UYK2W1W1EIACT
OREGANO0E5AT8T16UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEVOMENOL24WE03BX2TIACT
MALIC ACID817L1N4CKPIACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
cf486aa5-fce2-60fc-e053-2995a90a2fb50fa941ca-44a9-440f-b6bd-ab7ecf85bfaf2021-10-26WarningsExact identifier
spl id: cf486aa5-fce2-60fc-e053-2995a90a2fb5
spl set id: 0fa941ca-44a9-440f-b6bd-ab7ecf85bfaf

Reported adverse events (FAERS/openFDA)#

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