BB CREAM SPF 20 MEDIUM- octinoxate cream

BB Cream SPF 20 Medium by

Drug Labeling and Warnings

BB Cream SPF 20 Medium by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai Tianle Daily Chemical Factory, Columbia Cosmetic Manufacturing , Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Octisalate 5%

Oxybenzone 4%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

• Helps prevent sunburn
• If used 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

• 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

For sunscreen use:

• 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 sun cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m-2 p.m
  • wear long-sleeved shirt, pants, hats and sunglasses
  • children under 6 months of age: Ask doctor.

Inactive ingredients

Water (Aqua), Glycerin, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cydopentasiloxane, Cyclohexasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Quatemium-18 Bentonite, Quartz, Triethoxycaprylylsilane, Zinc Stearate, Talc, Vp/Hexadecene Copolymer, Bisabolol, Tocopheryl Acetate (Ve), Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leat Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Caprylyl Glycol, Fragrance (Parfum) May Contain: Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Titanium Dioxide (Cl 77891)

Questions or comments?

1-855-353-7320

Principal Display Panel - 28.5 mL Carton Label

e.l.f.

BB CREAM

SPF 20
sunscreen

MEDIUM

NET 0.96 FL. OZ. (28.5mL)

INGREDIENTS AND APPEARANCE

BB CREAM SPF 20 MEDIUM 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-753
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM CHLORATE (UNII: T95DR77GMR)
QUATERNIUM-18 (UNII: O7757NO1VL)
BENTONITE (UNII: A3N5ZCN45C)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC STEARATE (UNII: H92E6QA4FV)
TALC (UNII: 7SEV7J4R1U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ)
JOJOBA OIL (UNII: 724GKU717M)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-753-01	28.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/26/2018

Labeler - J. A. Cosmetics U.S. INC (186705047)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	MANUFACTURE(76354-753)