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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Glamcos L.L.C.

INN (International Name):

TITANIUM DIOXIDE

Composition:

TITANIUM DIOXIDE 79.2 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

EVERGLAM BB NATURAL BEIGE- TITANIUM DIOXIDE, OCTINOXATE, AND ZINC
OXIDE CREAM
GLAMCOS L.L.C.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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EVERGLAM BB CREAM NATURAL BEIGE
DRUG FACTS
_ACTIVE INGREDIENTS_
_PURPOSE_
Titanium Dioxide 7.920%
Sunscreen
Octinoxate 2.99%
Sunscreen
Zinc Oxide 1.900%
Sunscreen
US ES
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:
-
-
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
Limit time spent in the sun, especially from 10 a.m. - 2p.m.
Wear protective cloths, hats & sunglasses
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,
Ethylhexylg