BROAD SPECTRUM SPF45- zinc oxide, octinoxate gel 
Neutraderm, Inc.

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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Broad Spectrum SPF45

Drug Facts

Active ingredient

Zinc Oxide 12%

Octinoxate 7.5%

Purpose

Sunscreen

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 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.

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 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

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

SPF45

BROAD SPECTRUM SPF45 
zinc oxide, octinoxate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39765-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39765-035-0157 g in 1 BOTTLE; Type 0: Not a Combination Product01/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/06/2020
Labeler - Neutraderm, Inc. (146224444)
Establishment
NameAddressID/FEIBusiness Operations
Neutraderm, Inc.146224444manufacture(39765-035)

Revised: 6/2020
Document Id: 1638bba3-b0ce-43f9-8fcc-77902aad1e3d
Set id: 66237771-bef5-4403-98cd-f0eb91f86e24
Version: 1
Effective Time: 20200622
 
Neutraderm, Inc.