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NDC 41163-0943-64 Supervalue Equaline Sport SPF 50 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g Details

Supervalue Equaline Sport SPF 50 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g

Supervalue Equaline Sport SPF 50 is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by SUPERVALU INC.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	41163-0943
Product ID	41163-943_bc414041-e31e-710a-e053-2995a90afe04
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	Supervalue Equaline Sport SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 40; 50
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	SUPERVALU INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41163-0943-64 (41163094364)

Pricing Information	N/A
NDC Package Code	41163-943-64
Billing NDC	41163094364
Package	414 CAN in 1 PACKAGE (41163-943-64) / 207 g in 1 CAN (41163-943-86)
Marketing Start Date	2014-01-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bc414e07-72ea-8a27-e053-2995a90a4e74 Details

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%

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 near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

Do not use

on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

Stop use and ask 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.

Directions

• apply liberally 15 minutes before sun exposure

• hold can 4-6 inches away from body, spray evenly to ensure complete coverage

• do not spray into face. Spray into hand and apply to face.

• use in well ventilated, but not windy areas

• 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

Other Information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

alcohol denat. (73.2% v/v), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride.

Label

Supervalu Equaline Sport SPF 50 Continuous Spray

NDC 41163-943-86

7.3 oz (207 g)

Supervalu Equaline Sport SPF 50 Continuous Spray

NDC 41163-943-64

2 x 7.3 oz (207 g)

INGREDIENTS AND APPEARANCE

SUPERVALUE EQUALINE SPORT SPF 50

avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-943
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-943-64	414 in 1 PACKAGE	01/10/2014
1	NDC:41163-943-86	207 g in 1 CAN; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/10/2014

Labeler - SUPERVALU INC. (006961411)

Revised: 2/2021

Document Id: bc414041-e31e-710a-e053-2995a90afe04

Set id: bc414e07-72ea-8a27-e053-2995a90a4e74

Version: 1

Effective Time: 20210226

Search by Drug Name or NDC

NDC 41163-0943-64 Supervalue Equaline Sport SPF 50 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g Details

Supervalue Equaline Sport SPF 50 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 41163-0943-64 (41163094364)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL bc414e07-72ea-8a27-e053-2995a90a4e74 Details

Active ingredients

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask doctor if

Keep out of reach of children.

Directions

Other Information

Inactive ingredients

Label

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?

Search by Drug Name or NDC

NDC 41163-0943-64 Supervalue Equaline Sport SPF 50 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g Details

Supervalue Equaline Sport SPF 50 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 41163-0943-64 (41163094364)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL bc414e07-72ea-8a27-e053-2995a90a4e74 Details

Active ingredients

Purpose

Uses

Warnings

​Do not use

When using this product

​Stop use and ask doctor if​

Keep out of reach of children.

Directions

Other Information

Inactive ingredients

Label

INGREDIENTS AND APPEARANCE

Do not use

Stop use and ask doctor if