CARECELLA VELVET COVER BB CREAM NO 25- octyl methoxycinnamate, titanium dioxide, zinc oxide cream

Carecella Velvet Cover BB Cream No 25 by

Drug Labeling and Warnings

Carecella Velvet Cover BB Cream No 25 by is a Otc medication manufactured, distributed, or labeled by General Bio Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octyl Methoxycinnamate (7.5%)

Titanium Dioxide (4.2%)
Zinc Oxide (7%)

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps to prevent sunburn

WARNINGS

For external use only.

DO NOT USE

• if you are allergic to any of the ingredients
• on damaged or broken skin

WHEN USING

• keep out of eyes. Rinse with water to remove.

STOP USE

• rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• Apply liberally on cleansed skin 15 minutes prior to sun exposure.
• Reapply as needed or after towel drying, swimming or sweating.
• At least every 2 hours
• Children under 6 months: Ask a doctor.

OTHER SAFETY INFORMATION

• Store in a cool dry place away from direct sunlight.
• (You may add “high sun protection product” for SPF protection 30 or above)
• “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.”

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Zinc Oxide, Titanium Dioxide, Butylene Glycol, Titanium Dioxide, Aluminum Hydroxide, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Palmitate, Sorbitan Sesquioleate, Caprylic/Capric, Triglyceride, Arbutin, Cyclopentasiloxane, Dimethicone, PEG-10 Dimethicone Crosspolymer, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Hydroxyacetophenone, Caprylyl Glycol, CI 77492, 1,2-Hexanediol, Sodium Chloride, Beeswax, CI 77491, Magnesium Aluminum Silicate, Disteardimonium Hectorite, CI 77499, Ozokerite, Lavandula Angustifolia (Lavender) Oil, Linalool, Adenosine, Allantoin, Panthenol, Chamomilla, Recutita (Matricaria) Flower Extract, Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CARECELLA VELVET COVER BB CREAM NO 25 
octyl methoxycinnamate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69422-1005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.2 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69422-1005-2	1 in 1 BOX	10/26/2020
1	NDC: 69422-1005-1	50 mL 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 Drug	M020	10/26/2020

Labeler - General Bio Co., Ltd. (695273863)

Registrant - General Bio Co., Ltd. (695273863)

Establishment
Name	Address	ID/FEI	Business Operations
General Bio Co., Ltd.		695273863	manufacture(69422-1005)