BB CREAM SPF 20 FAIR- octinoxate, octisalate, oxybenzone cream

BB Cream SPF 20 Fair by

Drug Labeling and Warnings

BB Cream SPF 20 Fair by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 6.0%

Octisalate 4.0%

Oxybenzone 3.5%

Purpose

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, Cyclopentasiloxane, 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

fair

NET 0.96 FL. OZ. (28.5mL)

INGREDIENTS AND APPEARANCE

BB CREAM SPF 20 FAIR 
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-861
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	35 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
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 CHLORIDE (UNII: 451W47IQ8X)
BENTOQUATAM (UNII: 7F465U79Q1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ZINC STEARATE (UNII: H92E6QA4FV)
TALC (UNII: 7SEV7J4R1U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
CUCUMBER (UNII: YY7C30VXJT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-861-01	28.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/07/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(76354-861)