GLOW RADIANT MOISTURIZER SPF 15- octinoxate, octocrylene, octisalate, oxybenzone, avobenzone cream

Glow Radiant Moisturizer SPF 15 by

Drug Labeling and Warnings

Glow Radiant Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc, Zhejiang Ayan Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 7.1%

Octocrylene 3.8%

Octisalate 4.5%

Oxybenzone 2.8%

Avobenzone 2.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin agining 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 product is 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 shirts, pants, hats and sunglasses

children under 6 months of age: Ask a doctor.

Inactive Ingredients

Water (Aqua), Butylene Glycol, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Mica, Cetearyl Olivate, Cyclopentasiloxane, Sorbitan Olivate, Stearic Acid, Cetearyl Alcohol, Dimethicone, Tocopheryl Acetate (Ve), Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea Butter), Hydrolyzed Hyaluronic Acid, Phenoxyethanol, Caprylyl Glycol, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Fragrance (Parfum), Disodium EDTA, Bisabolol, Synthetic Fluorphlogopite, Silica, Tin Oxide, MAY CONTAIN: Titanium Dioxide (CI 77891), Red 40 (CI 16035), Yellow 5 (CI 19140)

Questions or comments?

1-855-353-7320

Package Labeling:

INGREDIENTS AND APPEARANCE

GLOW RADIANT MOISTURIZER SPF 15 
octinoxate, octocrylene, octisalate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	71 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	38 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	28 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TROMETHAMINE (UNII: 023C2WHX2V)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-650-01	36 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(76354-650)