Label: CC CREAM SPF 30- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 79489-0010-0 - Packager: HAN Skin Care Cosmetics, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated October 26, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients(in each 30 ml)
- Uses
- warnings
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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.
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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
- Package Labeling
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INGREDIENTS AND APPEARANCE
CC CREAM SPF 30
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79489-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 210 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79489-0010-0 1 in 1 BOX 07/01/2020 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2020 Labeler - HAN Skin Care Cosmetics, LLC (039398075) Establishment Name Address ID/FEI Business Operations Columbia Cosmetics Manufacturing, Inc. 068267863 manufacture(79489-0010)
