NEXGEN SUNSCREEN BROAD SPECTRUM SPF 36 DOC MARTINS- octinoxate, oxybenzone, octocrylene, avobenzone cream

NexGen Sunscreen Broad Spectrum SPF 36 by

Drug Labeling and Warnings

NexGen Sunscreen Broad Spectrum SPF 36 by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active Ingredients:                           Purpose:

Octinoxate 7.0% Benzophenone-3    ​Sunscreen

(Oxybenzone) 5.0% Octocrylene 4.0% Avobenzone 3.0%

PURPOSE

​Uses:

Helps prevent sunburn. If used as described with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

​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.

DOSAGE & ADMINISTRATION

​Directions:

- Apply liberally 15 minutes before sun exposure.

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

- Children under 6 months: ask a doctor.

INACTIVE INGREDIENT

Beeswax, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cetyl Dimethicone, Cetyl Lactate, Cpernicia Cerifera (Carnauba) Wax, C10-30 Cholesterol/Lanosterol, Euphorbia Cerifera (Candelilla) Wax, Fragrance, Neopentyl Glycol Diheptanoate, Phenoxyethanol, Polybutene, Propylene Carbonate, Propylene Glycol Dibenzoate, Sea Whip Extract, Silica, Stearalkonium Hectorite

PRINCIPAL DISPLAY PANEL

Doc Martin's of Maui

NexGen Sunscreen

New Skin Bonding Technology

Broad Spectrum SPF 36

Water Resistant (80 minutes)

2.0 FL OZ (60 mL)

INGREDIENTS AND APPEARANCE

NEXGEN SUNSCREEN BROAD SPECTRUM SPF 36  DOC MARTINS
octinoxate, oxybenzone, octocrylene, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL LACTATE (UNII: A7EVH2RK4O)
CARNAUBA WAX (UNII: R12CBM0EIZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
CANDELILLA WAX (UNII: WL0328HX19)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5010-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	03/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/21/2017

Labeler - Cosmetic Enterprises Ltd. (017701475)

Registrant - Cosmetic Enterprises Ltd. (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd.		017701475	manufacture(56152-5010)