NUGLOW- avobenzone, octinoxate, and zinc oxide cream

NuGLOW by

Drug Labeling and Warnings

NuGLOW by is a Otc medication manufactured, distributed, or labeled by G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIRECTIONS

After cleansing, apply liberally to face daily. Apply evenly before sun exposure. Reapply as needed after towel drying, swimming or perspiring.

Children under 6 months: ask a doctor.

WARNINGS

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

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

QUESTIONS?

1-866-605-9510 or visit www.nuglowskincare.com.

PURPOSE

Daytime Therapy With SPF15

ACTIVE INGREDIENTS

Avobenzone 1.0%, Octinoxate 7.0%, Zinc Oxide 4.0%.

INACTIVE INGREDIENTS

Aqua (Water), Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Butyrospermum Parkii (Shea Butter), Polysorbate 60, Cetyl Alcohol, Dimethicone, Cetyl Ricinoleate, Stearyl Alcohol, Persea Gratissima (Avocado) Oil, Glycerin, Sodium Hyaluronate, Camellia Oleifera (Green Tea) Leaf Extract, Chrondrus Crispus (Carrageenan), Sodium PCA, Xanthan Gum, Tocopheryl Acetate, Ascorbic Acid, Lactic Acid, Glucose, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

SPL UNCLASSIFIED SECTION

For expiration date, see bottom of jar.

Made in the U.S.A. for NuGlow, Los Angeles, CA 90049

Reorder# 70825
Rev 8/10

PRINCIPAL DISPLAY PANEL - 34g Jar Label

NuGlow®

Daytime Therapy
With SPF15

Net Weight 1.2 Oz./34g e

INGREDIENTS AND APPEARANCE

NUGLOW   DAYTIME THERAPY WITH SPF 15
avobenzone, octinoxate, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65113-8503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
GLYCERIN (UNII: PDC6A3C0OX)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
XANTHAN GUM (UNII: TTV12P4NEE)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LACTIC ACID (UNII: 33X04XA5AT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65113-8503-3	34 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/15/2010

Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE