Label: CC CREAM DEEP240- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81123-313-01 - Packager: The Creme Shop Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 April 28, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Warnings
- Warnings
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Sun Protection 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 spectrum SPF of 15 of higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6months of age: Ask a doctor - Other Information
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Inactive Ingredient
Water, Sea Water, Dimethicone, Isododecane, Iron Oxide Yellow, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, Iron Oxide Red, Sodium Chloride, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxide Black, Phenoxyethanol, Sorbitan Isostearate, Triethoxycaprylylsilane, Ceresin, Silica, Magnesium Myristate, Magnesium Stearate, Sorbitan Sesquioleate, 1,2-Hexanediol, Synthetic Wax, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Dehydroacetic Acid, Disteardimonium Hectorite, Methicone, Adenosine, Propylene Carbonate, Canola Oil, Garcinia Indica Seed Butter, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Vitis vinifera (Grape) seed oil, Rose Centifolia Flower Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Centella Asiatica Extract, Glycerin, Glycine Soja (Soybean) Seed Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Oryza Sativa (Rice) Extract, Prunus Persica (Peach) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Sodium Hyaluronate
- Package Label
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INGREDIENTS AND APPEARANCE
CC CREAM DEEP240
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81123-313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.5 mg in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) CERESIN (UNII: Q1LS2UJO3A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DEHYDROACETIC ACID (UNII: 2KAG279R6R) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISODODECANE (UNII: A8289P68Y2) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) FERRIC OXIDE RED (UNII: 1K09F3G675) SUNFLOWER OIL (UNII: 3W1JG795YI) GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800) CENTELLA ASIATICA (UNII: 7M867G6T1U) MAGNESIUM MYRISTATE (UNII: Z1917F0578) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) LAVENDER OIL (UNII: ZBP1YXW0H8) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BEACH STRAWBERRY (UNII: 98542F2TQS) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CANOLA OIL (UNII: 331KBJ17RK) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ADENOSINE (UNII: K72T3FS567) GRAPE SEED OIL (UNII: 930MLC8XGG) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) ORANGE (UNII: 5EVU04N5QU) ALOE VERA LEAF (UNII: ZY81Z83H0X) RICE GERM (UNII: 7N2B70SFEZ) PEACH (UNII: 3OKE88I3QG) MAGNESIUM STEARATE (UNII: 70097M6I30) SOYBEAN (UNII: L7HT8F1ZOD) COCONUT (UNII: 3RT3536DHY) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81123-313-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/08/2020 Labeler - The Creme Shop Inc (052907070) Registrant - The Creme Shop Inc (052907070) Establishment Name Address ID/FEI Business Operations ANNE Cosmetics 690377762 manufacture(81123-313)
