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NDC 13630-0256-04 The Venetian The Palazzo 25.17; 125.85; 41.95; 23.07 g/mL; g/mL; g/mL; g/mL Details

The Venetian The Palazzo 25.17; 125.85; 41.95; 23.07 g/mL; g/mL; g/mL; g/mL

The Venetian The Palazzo is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Prime Packaging Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	13630-0256
Product ID	13630-0256_ecf7cbd1-b7d2-431d-e053-2995a90a0434
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	The Venetian The Palazzo
Proprietary Name Suffix	Broad Spectrum SPF 50 Sunscreen
Non-Proprietary Name	Homosalate, Octisalate, Avobenzone, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	25.17; 125.85; 41.95; 23.07
Active Ingredient Units	g/mL; g/mL; g/mL; g/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Prime Packaging Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M020
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13630-0256-04 (13630025604)

Pricing Information	N/A
NDC Package Code	13630-0256-4
Billing NDC	13630025604
Package	177 mL in 1 CAN (13630-0256-4)
Marketing Start Date	2015-08-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ecf7d078-8729-a8d1-e053-2a95a90a4e72 Details

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 2.75%

Purpose

Sunscreen

Uses

Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging 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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120º F.

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.

Flammable: Do not use near heat, flame or while smoking

Directions

Spray liberally and spread evenly 15 minutes before sun exposure
Hold container 4 to 6 inches from the skin to apply
Do not spray directly into face. Spray on hands then apply to face.
Do not apply in windy conditions
Use in well-ventilated area
Reapply:
After 80 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours.
Sun Protection Measures 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 SPF of 15 or higher and other sun protecion measures including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Diethylhexyl 2,6-Naphthalate, Mineral Oil, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

Protect this product from excessive heat and direct sun
Avoid spraying on fabrics - could cause discoloration
Store at 20° to 25°C (68° to 77°F)

Questions or Comments?

Call toll free 1-800-950-2563 or visit www.aloeup.com

Aloe up Sport Performace Sunscreen Broad spectrum SPF 50

INGREDIENTS AND APPEARANCE

THE VENETIAN THE PALAZZO BROAD SPECTRUM SPF 50 SUNSCREEN

homosalate, octisalate, avobenzone, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0256
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.07 g in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.17 g in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.95 g in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	125.85 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
MINERAL OIL (UNII: T5L8T28FGP)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0256-4	177 mL in 1 CAN; Type 0: Not a Combination Product	08/28/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	08/28/2015

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	manufacture(13630-0256) , label(13630-0256) , pack(13630-0256) , analysis(13630-0256)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging Inc.		805987059	label(13630-0256) , pack(13630-0256)

Revised: 11/2022

Document Id: ecf7cbd1-b7d2-431d-e053-2995a90a0434

Set id: ecf7d078-8729-a8d1-e053-2a95a90a4e72

Version: 1

Effective Time: 20221108