CC CREAM TAN200- zinc oxide, 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.

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81123-309 Tan200

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: 81123-309

CC CREAM TAN200 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81123-309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.5 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ADENOSINE (UNII: K72T3FS567)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ISODODECANE (UNII: A8289P68Y2)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
PEACH (UNII: 3OKE88I3QG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
CANOLA OIL (UNII: 331KBJ17RK)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
ORANGE (UNII: 5EVU04N5QU)  
SOYBEAN (UNII: L7HT8F1ZOD)  
CERESIN (UNII: Q1LS2UJO3A)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
RICE GERM (UNII: 7N2B70SFEZ)  
BEACH STRAWBERRY (UNII: 98542F2TQS)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
COCONUT (UNII: 3RT3536DHY)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81123-309-0150 mL in 1 TUBE; Type 0: Not a Combination Product11/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/20/2020
Labeler - The Creme Shop Inc (052907070)
Registrant - The Creme Shop Inc (052907070)
Establishment
NameAddressID/FEIBusiness Operations
ANNE Cosmetics690377762manufacture(81123-309)

Revised: 5/2022
Document Id: de17ccc1-3ad5-2962-e053-2a95a90a4ef4
Set id: b54e6b72-049d-72fa-e053-2a95a90ab18b
Version: 8
Effective Time: 20220503
 
The Creme Shop Inc