CC CREAM TAN200- zinc oxide, titanium dioxide cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
The Creme Shop Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps prevent sunburn. 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.
Authorization status:
OTC monograph not final
Authorization number:
81123-309-01

Read the complete document

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.

----------

81123-309 Tan200

Active Ingredient

Titanium Dioxide 5.5%

Zinc Oxide 5.5%

Purpos e

Helps prevent sunburn.

Us es

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

CC CREAM TAN200

zinc oxide, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 1123-30 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

5.5 mg in 10 0 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

5.5 mg in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

DEHYDRO ACETIC ACID (UNII: 2KAG279 R6 R)

CANO LA O IL (UNII: 331KBJ17RK)

LAVENDER O IL (UNII: ZBP1YXW0 H8 )

GLYCERIN (UNII: PDC6 A3C0 OX)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SO RBITAN ISO STEARATE (UNII: 0 1S2G2C1E4)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

RO SA CENTIFO LIA FLO WER (UNII: CS4TE8 FF7O)

O RANGE (UNII: 5EVU0 4N5QU)

SO YBEAN (UNII: L7HT8 F1ZOD)

CERESIN (UNII: Q1LS2UJO3A)

CENTELLA ASIATICA (UNII: 7M8 6 7G6 T1U)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

RICE GERM (UNII: 7N2B70 SFEZ)

BEACH STRAWBERRY (UNII: 9 8 542F2TQS)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

CO CO NUT (UNII: 3RT3536 DHY)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 2 ) (UNII: V2W71V8 T0 X)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

LAURYL PEG-9 PO LYDIMETHYLSILO XYETHYL DIMETHICO NE (UNII: 25G6 22K2RA)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

ADENO SINE (UNII: K72T3FS56 7)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

MAGNESIUM MYRISTATE (UNII: Z19 17F0 578 )

SO RBITAN SESQ UIO LEATE (UNII: 0 W8 RRI5W5A)

SYNTHETIC WAX ( 12 0 0 MW) (UNII: Q3Z4BCH0 9 9 )

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( SO FT PARTICLE) (UNII: 9 E4CO0 W6 C5)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

GARCINIA INDICA SEED BUTTER (UNII: US2H3D78 0 0 )

GRAPE SEED O IL (UNII: 9 30 MLC8 XGG)

PEACH (UNII: 3OKE8 8 I3QG)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

The Creme Shop Inc

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 1123-30 9 -0 1

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

11/20 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

11/20 /20 20

Labeler -

T he Creme Shop Inc (052907070)

Registrant -

T he Creme Shop Inc (052907070)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Anneu Co ., Ltd.

6 9 0 37776 2

ma nufa c ture (8 1123-30 9 )

Revised: 12/2020

Similar products

Search alerts related to this product

View documents history

Share this information