CC CREAM MEDIUM140- titanium dioxide, zinc oxide 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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81123-327 Medium140

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 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

81123-327

CC CREAM MEDIUM140 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81123-327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CERESIN (UNII: Q1LS2UJO3A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
ORANGE (UNII: 5EVU04N5QU)  
SOYBEAN (UNII: L7HT8F1ZOD)  
BEACH STRAWBERRY (UNII: 98542F2TQS)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
RICE GERM (UNII: 7N2B70SFEZ)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEACH (UNII: 3OKE88I3QG)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
COCONUT (UNII: 3RT3536DHY)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ADENOSINE (UNII: K72T3FS567)  
CANOLA OIL (UNII: 331KBJ17RK)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81123-327-0150 mg in 1 TUBE; Type 0: Not a Combination Product12/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/11/2020
Labeler - The Creme Shop Inc (052907070)
Registrant - The Creme Shop Inc (052907070)
Establishment
NameAddressID/FEIBusiness Operations
Anneu Co., Ltd.690377762manufacture(81123-327)

Revised: 5/2021
Document Id: c2ba1b39-622e-481e-e053-2a95a90a8637
Set id: b62a9948-4a75-5ef4-e053-2a95a90a5562
Version: 21
Effective Time: 20210517
 
The Creme Shop Inc