CC CREAM SPF 30- zinc oxide, titanium dioxide cream 
HAN Skin Care Cosmetics, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CC Cream SPF 30

Drug Facts

Active Ingredients(in each 30 ml)

Zinc Oxide 21%

Titanium Dioxide 6%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

warnings

  • For external use only.

Do not use

  • on damaged or broken skin.

When using this product,

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

Stop use and ask a doctor

  • if rash or irritation develops and lasts.

Keep out of reach of children.

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

Directions

  • 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

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

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

Package Labeling

Bottle

CC CREAM SPF 30 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79489-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION210 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT ALKANES (UNII: 1E5KJY107T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
TRICAPRILIN (UNII: 6P92858988)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CASTOR OIL (UNII: D5340Y2I9G)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
GLYCERIN (UNII: PDC6A3C0OX)  
ORANGE PEEL WAX (UNII: 0U715N387C)  
JOJOBA OIL (UNII: 724GKU717M)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRIC ACID (UNII: 4G9EDB6V73)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
KAOLIN (UNII: 24H4NWX5CO)  
ARGAN OIL (UNII: 4V59G5UW9X)  
ROSA MOSCHATA OIL (UNII: J99W255AWF)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
OREGANO (UNII: 0E5AT8T16U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LEVOMENOL (UNII: 24WE03BX2T)  
MALIC ACID (UNII: 817L1N4CKP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79489-0010-01 in 1 BOX07/01/2020
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2020
Labeler - HAN Skin Care Cosmetics, LLC (039398075)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture(79489-0010)

Revised: 7/2020
Document Id: a9fff66a-9519-e73d-e053-2a95a90a2ded
Set id: 0fa941ca-44a9-440f-b6bd-ab7ecf85bfaf
Version: 1
Effective Time: 20200709
 
HAN Skin Care Cosmetics, LLC