CC Cream Deep220: Package Insert and Label Information

CC CREAM DEEP220- zinc oxide and titanium dioxide cream
The Creme Shop Inc

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.

Active Ingredient

Titanium Dioxide 5.5%

Zinc Oxide 5.5%

Purpose

Helps prevent sunburn.

Uses

If uses as directed with other sun protection measures(see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Rinse with water to remove.

If swallowed, get medical help or contact Poison Control Center right away.

Warnings

Do not use on damaged or broken skin.

Warnings

Keep out of reach of children.

Warnings

Stop use and ask a doctor if rash occurs.

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

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

Inactive Ingredients

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

50ml NDC: 81123-310
(click image for full-size original)

CC CREAM DEEP220
zinc oxide, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81123-310
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.5 mg in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 5.5 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
PHENYL TRIMETHICONE
BUTYLENE GLYCOL
DEHYDROACETIC ACID
CANOLA OIL
LAVENDER OIL
GLYCERIN
DIMETHICONE
SORBITAN ISOSTEARATE
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE
ROSA CENTIFOLIA FLOWER
ORANGE
SOYBEAN
CERESIN
CENTELLA ASIATICA
ALOE VERA LEAF
GREEN TEA LEAF
RICE GERM
BEACH STRAWBERRY
HYALURONATE SODIUM
COCONUT
FERRIC OXIDE YELLOW
MEDIUM-CHAIN TRIGLYCERIDES
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
FERRIC OXIDE RED
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
FERROSOFERRIC OXIDE
SILICON DIOXIDE
MAGNESIUM STEARATE
1,2-HEXANEDIOL
ADENOSINE
SUNFLOWER OIL
ISODODECANE
MAGNESIUM MYRISTATE
SORBITAN SESQUIOLEATE
SYNTHETIC WAX (1200 MW)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
ALUMINUM HYDROXIDE
ETHYLHEXYLGLYCERIN
DISTEARDIMONIUM HECTORITE
METHICONE (20 CST)
GARCINIA INDICA SEED BUTTER
GRAPE SEED OIL
PEACH
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81123-310-01 50 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/20/2020
Labeler — The Creme Shop Inc (052907070)
Registrant — The Creme Shop Inc (052907070)
Establishment
Name Address ID/FEI Operations
Anneu Co., Ltd. 690377762 manufacture (81123-310)

Revised: 11/2020 The Creme Shop Inc

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