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NDC 41163-0954-48 EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 30; 100; 50; 20 mg/g; mg/g; mg/g; mg/g Details

EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 30; 100; 50; 20 mg/g; mg/g; mg/g; mg/g

EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 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.

Product Information

NDC	41163-0954
Product ID	41163-954_e46d254a-c7b3-291f-e053-2995a90a8f3a
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	EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 20
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
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 41163-0954-48 (41163095448)

Pricing Information	N/A
NDC Package Code	41163-954-48
Billing NDC	41163095448
Package	258 g in 1 CAN (41163-954-48)
Marketing Start Date	2020-10-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e46d20b3-2897-1370-e053-2a95a90a619c Details

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%

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

FLAMMABLE:

• 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.

• keep away from face to avoid breathing it.

• do not puncture or incinerate. Contents under pressure.

• do not store at temperatures above 120°F.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Spray liberally and spread evenly by hand 15 minutes before sun exposure
Hold can 4-6 inches away from the skin to apply
Do not spray directly into face. Spray into 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

Children under 6 months of age: Ask a doctor
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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive ingredients

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-954
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	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-954-63	2 in 1 PACKAGE	10/14/2020
1	NDC:41163-954-37	156 g in 1 CAN; Type 0: Not a Combination Product
2	NDC:41163-954-48	258 g in 1 CAN; Type 0: Not a Combination Product	10/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/14/2020

Labeler - SUPERVALU INC. (006961411)

Revised: 7/2022

Document Id: e46d254a-c7b3-291f-e053-2995a90a8f3a

Set id: e46d20b3-2897-1370-e053-2a95a90a619c

Version: 1

Effective Time: 20220722

Search by Drug Name or NDC

NDC 41163-0954-48 EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 30; 100; 50; 20 mg/g; mg/g; mg/g; mg/g Details

EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 30; 100; 50; 20 mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 41163-0954-48 (41163095448)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e46d20b3-2897-1370-e053-2a95a90a619c Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE:

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

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 41163-0954-48 EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 30; 100; 50; 20 mg/g; mg/g; mg/g; mg/g Details

EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 30; 100; 50; 20 mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 41163-0954-48 (41163095448)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e46d20b3-2897-1370-e053-2a95a90a619c Details

﻿Active ingredients

Purpose

Uses

Warnings

FLAMMABLE:

﻿Do not use﻿

﻿When using this product﻿

﻿Stop use and ask a doctor if﻿

﻿Keep out of reach of children﻿.

﻿Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Active ingredients

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions