Carecella Velvet Cover BB Cream

Drug Labeling and Warnings

Drug Details [pdf]

CARECELLA VELVET COVER BB CREAM- ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream 
General Bio Co., Ltd.

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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Carecella Velvet Cover BB Cream

Directions

Apply the adequate amount onto the entire face at the last stage of your skin care routine.

Apply liberally 15 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Children under 6 months of age: ask a doctor

Warnings

For external use only

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Do not use when skin is red, inflamed, irritated, or painful

When using this product

do not apply on other parts of the body

do not use on damaged or broken skin

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

do not apply directly to wound or open cut

Stop use and ask a doctor if

Rash or irritation on skin develops and lasts

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Palmitate, Sorbitan Sesquioleate, Caprylic/Capric Triglyceride, Arbutin, Dimethicone, Dipropylene Glycol, CI 77492, Sodium Chloride, 1,2-Hexanediol, Beeswax,Disteardimonium Hectorite, Magnesium Aluminum Silicate,CI 77491, Hydroxyacetophenone,

Dimethicone/Vinyl Dimethicone Crosspolymer, CI 77499,PEG-10 Dimethicone Crosspolymer, Ozokerite,Aluminum Hydroxide, Triethoxycaprylylsilane, Lavandula Angustifolia (Lavender) Oil, Adenosine, Allantoin, Panthenol,

Chamomilla Recutita (Matricaria) Flower Extract,

Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract, Caprylyl Glycol.

Uses

Helps prevent sunburn

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

Sunscreen

Active Ingredient

Ethylhexyl Methoxycinnamate (7.5%) ----- Sunscreen

Titanium Dioxide (8%) ------------------------- Sunscreen

Zinc Oxide (7%) --------------------------------- Sunscreen

Carecella Velvet Cover BB Cream

CARECELLA VELVET COVER BB CREAM 
ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69422-1002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.5 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69422-1002-2	1 in 1 BOX	11/21/2018
1	NDC: 69422-1002-1	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/21/2018	09/30/2019

Labeler - General Bio Co., Ltd. (688299527)

Registrant - General Bio Co., Ltd. (688299527)

Establishment
Name	Address	ID/FEI	Business Operations
General Bio Co., Ltd.		688299527	manufacture(69422-1002)

Revised: 10/2019

Document Id: 9626271b-276b-2eda-e053-2a95a90a01e4

34390-5

Set id: 7b33ba74-e160-621c-e053-2a91aa0a06a4

Version: 2

Effective Time: 20191030