BROAD SPECTRUM SPF45- zinc oxide, octinoxate gel

Broad Spectrum SPF45 by

Drug Labeling and Warnings

Broad Spectrum SPF45 by is a Otc medication manufactured, distributed, or labeled by Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 12%

Octinoxate 7.5%

Purpose

Sunscreen

INDICATIONS & USAGE

Use Helps prevent sunburn If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

Warnings For external use only.

When using this product  keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.

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

DOSAGE & ADMINISTRATION

Directions  Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician.

Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying at least every 2 hours.

Precautions Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF 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 physician.

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane

SPL UNCLASSIFIED SECTION

DRMTLGY®

MEDICAL GRADE SKIN CARE

Anti-Aging

Protects Against UV Rays

High Purity

Niacinamide and Hyaluronic Acid

Transparent Zinc Oxide

DRMTLGY, LLC
Chatsworth, CA

www.DRMTLGY.com

Made In USA

Packaging

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF45 
zinc oxide, octinoxate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39765-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NIACINAMIDE (UNII: 25X51I8RD4)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39765-035-01	57 g in 1 BOTTLE; Type 0: Not a Combination Product	01/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/06/2020

Labeler - Neutraderm, Inc. (146224444)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture(39765-035)