EVERGLAM BB NATURAL BEIGE- titanium dioxide, octinoxate, and zinc oxide cream

EverGlam BB Natural Beige by

Drug Labeling and Warnings

EverGlam BB Natural Beige by is a Otc medication manufactured, distributed, or labeled by Glamcos L.L.C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 7.920%	Sunscreen
Octinoxate 2.99%	Sunscreen
Zinc Oxide 1.900%	Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases 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.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if a rash occurs.

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• If swimming or sweating, use a water resistant sunscreen
• Children under 6 months: Consult a doctor
• Sun Protection Measures:
  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • - Limit time spent in the sun, especially from 10 a.m. - 2p.m.
  • - Wear protective cloths, hats & sunglasses

Other information

• Keep this product away from direct sunlight and excessive heat
• You may report a serious adverse event from use of this product to: GlamCos LLC, 708 Third Ave, 6th Floor, New York, NY 10017

Inactive ingredients

Water, Cyclopentasiloxane, Glycerin, TALC, Dipropylene Glycol, PEG-10 Dimethicone, Hexyl Laurate, Dimethicone, Disteardimonium Hectorite, Betaine, Isoeicosane, Iron Oxides(CI 77492), Magnesium Sulfate, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides(CI 77499), Iron Oxides(CI 77491), Acrylates/Dimethicone Copolymer, Phenoxyethanol, Methicone, Palmitic Acid, Ethylhexylglycerin, Portulaca Oleracea Extract, Tocopheryl Acetate, Fragrance, Aluminum Hydroxide, Aluminum Stearate, Butylated Hydroxytoluene, Sagassum Fulvellum Extract, Butylene Glycol, 1,2-Hexanediol

Questions & Comments?

Call 800-922-8459

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

EverGlam
Advanced Skincare

BB
BEAUTY BALM
FOR FLAWLESS COVERAGE

NATURAL BEIGE

ADVANCED MULTI- ACTION
SKINCARE + MAKEUP

• Concealing Skin Imperfections
• Moisturizing with Oil Control
• Rejuvenating and Anti-Wrinkle
• Sunscreen

Broad Spectrum
SPF 30

50 mL / 1.7 fl. oz.

INGREDIENTS AND APPEARANCE

EVERGLAM BB NATURAL BEIGE 
titanium dioxide, octinoxate, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71667-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	79.2 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	29.9 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Glycerin (UNII: PDC6A3C0OX)
Talc (UNII: 7SEV7J4R1U)
Dipropylene Glycol (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Dimethicone (UNII: 92RU3N3Y1O)
Disteardimonium Hectorite (UNII: X687XDK09L)
Betaine (UNII: 3SCV180C9W)
Isoeicosane (UNII: AR294KAG3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methicone (20 Cst) (UNII: 6777U11MKT)
Palmitic Acid (UNII: 2V16EO95H1)
Ethylhexylglycerin (UNII: 147D247K3P)
PURSLANE (UNII: M6S840WXG5)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
ALUMINUM MONOSTEARATE (UNII: P9BC99461E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Sargassum Fulvellum (UNII: 245PL7LPSU)
Butylene Glycol (UNII: 3XUS85K0RA)
1,2-Hexanediol (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71667-200-01	1 in 1 BOX	09/15/2017
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 FINAL	part352	09/15/2017

Labeler - Glamcos L.L.C. (080544953)