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NDC 41163-0953-37 EQUALINE KIDS SPF 50 30; 100; 50; 40 mg/g; mg/g; mg/g; mg/g Details

EQUALINE KIDS SPF 50 30; 100; 50; 40 mg/g; mg/g; mg/g; mg/g

EQUALINE KIDS 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.

Product Information

NDC	41163-0953
Product ID	41163-953_e46cb6e3-ea8e-3c2d-e053-2a95a90a0bf6
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 KIDS SPF 50
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; 40
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 41163-0953-37 (41163095337)

Pricing Information	N/A
NDC Package Code	41163-953-37
Billing NDC	41163095337
Package	156 g in 1 CAN (41163-953-37)
Marketing Start Date	2020-10-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e46cb6e3-ea8d-3c2d-e053-2a95a90a0bf6 Details

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 4.0%

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 104ºF (40ºC)

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 120ºF.

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 minutres 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 prodcut 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 KIDS SPF 50

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-953
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-953-37	156 g in 1 CAN; Type 0: Not a Combination Product	10/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/15/2020

Labeler - SUPERVALU INC. (006961411)

Revised: 7/2022

Document Id: e46cb6e3-ea8e-3c2d-e053-2a95a90a0bf6

Set id: e46cb6e3-ea8d-3c2d-e053-2a95a90a0bf6

Version: 1

Effective Time: 20220722