CY BB FACIAL HIDRATANTE CON COLOR FPS 25 MULTIBENEFICIOS- octinoxate and zinc oxide cream

CY BB Facial Hidratante con Color FPS 25 Multibeneficios by

Drug Labeling and Warnings

CY BB Facial Hidratante con Color FPS 25 Multibeneficios by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
ZINC OXIDE 8.4%	Sunscreen
OCTINOXATE 7%	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• 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.

• For external use only.

• Do not use on damaged or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

WATER, DIMETHICONE, PEG-10 DIMETHICONE, GLYCERIN, PEG/PPG-18/18 DIMETHICONE, POLYMETHYLSILSESQUIOXANE, POLYSILICONE-11, SILICA, HYDROXYACETOPHENONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHENOXYETHANOL, BUTYLENE GLYCOL, SODIUM CHLORIDE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, CHLORPHENESIN, SILANEDIOL SALICYLATE, TROMETHAMINE, TRIETHOXYCAPRYLYLSILANE, THEOBROMA CACAO (COCOA) SEED EXTRACT. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp.
Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 25 g Tube Box

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BB CREAM

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Net wt. 0.88 oz. e (25 g)

INGREDIENTS AND APPEARANCE

CY BB FACIAL HIDRATANTE CON COLOR FPS 25 MULTIBENEFICIOS 
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.084 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
TROMETHAMINE (UNII: 023C2WHX2V)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
COCOA (UNII: D9108TZ9KG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0078-2	1 in 1 BOX	12/01/2017
1	NDC: 43596-0078-1	25 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 FINAL	part352	12/01/2017

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0078)