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NDC 13630-0257-04 Aloe Up 25.41; 127.05; 42.35; 23.29 g/mL; g/mL; g/mL; g/mL Details

Aloe Up 25.41; 127.05; 42.35; 23.29 g/mL; g/mL; g/mL; g/mL

Aloe Up 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	13630-0257
Product ID	13630-0257_ecf84130-55e6-fe21-e053-2a95a90ab08a
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	Aloe Up
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	25.41; 127.05; 42.35; 23.29
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 13630-0257-04 (13630025704)

Pricing Information	N/A
NDC Package Code	13630-0257-4
Billing NDC	13630025704
Package	184 mL in 1 CAN (13630-0257-4)
Marketing Start Date	2017-10-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ecf7a2a2-6a43-2e1c-e053-2a95a90aec90 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 by hand 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, Fragrance (Parfum), Mineral Oil (Paraffinum Liquidum), Polyester-8, SD Alcohol 40-B (Alcohol Denat.), 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

Aloe up Sport Performace Sunscreen Broad spectrum SPF 50

INGREDIENTS AND APPEARANCE

ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN

homosalate, octisalate, avobenzone, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0257
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.29 g in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.41 g in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.35 g in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	127.05 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:13630-0257-4	184 mL in 1 CAN; Type 0: Not a Combination Product	10/25/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/25/2017

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	manufacture(13630-0257) , label(13630-0257) , pack(13630-0257) , analysis(13630-0257)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging Inc.		805987059	label(13630-0257) , pack(13630-0257)

Revised: 11/2022

Document Id: ecf84130-55e6-fe21-e053-2a95a90ab08a

Set id: ecf7a2a2-6a43-2e1c-e053-2a95a90aec90

Version: 1

Effective Time: 20221108