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NDC 13630-0251-04 Hurley 16.4; 41.1; 16.4 mg/mL; mg/mL; mg/mL Details

Hurley 16.4; 41.1; 16.4 mg/mL; mg/mL; mg/mL

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

Product Information

NDC	13630-0251
Product ID	13630-0251_e9bd1c3a-306c-b637-e053-2995a90acfd2
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	Hurley
Proprietary Name Suffix	Sunscreen Broad Spectrum SPF15
Non-Proprietary Name	Avobenzone, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	16.4; 41.1; 16.4
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; OCTISALATE; OCTOCRYLENE
Labeler Name	Prime Packaging, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13630-0251-04 (13630025104)

Pricing Information	N/A
NDC Package Code	13630-0251-4
Billing NDC	13630025104
Package	190 mL in 1 CAN (13630-0251-4)
Marketing Start Date	2020-05-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e9bd1d38-3a55-4f06-e053-2995a90a2de4 Details

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 2%

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.

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. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

Directions

• shake well before use • apply liberally 15 minutes before sun exposure and rub into skin • 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 a 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 protection 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

Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer.

Other information

• Protect this product from excessive heat and direct sun.

• Avoid spraying on fabrics - could cause discoloration.

Questions or comments?

Email [email protected]

Hurley Broad Spectrum SPF15 Sunscreen Spray

INGREDIENTS AND APPEARANCE

HURLEY SUNSCREEN BROAD SPECTRUM SPF15

avobenzone, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0251
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	16.4 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.1 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	16.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Product Characteristics
Color	white (Colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0251-4	190 mL in 1 CAN; Type 0: Not a Combination Product	05/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/05/2020

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0251) , analysis(13630-0251)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0251) , pack(13630-0251)

Revised: 9/2022

Document Id: e9bd1c3a-306c-b637-e053-2995a90acfd2

Set id: e9bd1d38-3a55-4f06-e053-2995a90a2de4

Version: 1

Effective Time: 20220928