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NDC 36800-0186-63 TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 20; 70; 50 mg/g; mg/g; mg/g Details

TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 20; 70; 50 mg/g; mg/g; mg/g

TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTOCRYLENE.

Product Information

NDC	36800-0186
Product ID	36800-186_c8aefe71-d6e1-2767-e053-2995a90a9bab
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	TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octocrylene,
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	20; 70; 50
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Labeler Name	TOPCO ASSOCIATES LLC
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 36800-0186-63 (36800018663)

Pricing Information	N/A
NDC Package Code	36800-186-63
Billing NDC	36800018663
Package	2 CAN in 1 PACKAGE (36800-186-63) / 156 g in 1 CAN (36800-186-37)
Marketing Start Date	2018-12-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c8af028e-9d68-4023-e053-2995a90ad18a Details

Active ingredients

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 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

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 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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away fromskin to apply

• Do not spray into face. Spray into hand then apply to face.

• Use in well ventilated area

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

children under 6 months: 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., Isododecane, Diisopropyl Adipate, Acrylates/Octylacrylamide Copolymer, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, PEG-12 Dimethicone, Caprylyl Glycol, Hydrogenated Methyl Abietate, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30

avobenzone, homosalate, octocrylene, aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-186
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-186-63	2 in 1 PACKAGE	12/20/2018
1	NDC:36800-186-37	156 g in 1 CAN; Type 0: Not a Combination Product
2	NDC:36800-186-37	156 g in 1 CAN; Type 0: Not a Combination Product	12/20/2018
3	NDC:36800-186-62	3 in 1 PACKAGE	12/20/2018
3	NDC:36800-186-37	156 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	12/20/2018

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 8/2021

Document Id: c8aefe71-d6e1-2767-e053-2995a90a9bab

Set id: c8af028e-9d68-4023-e053-2995a90ad18a

Version: 1

Effective Time: 20210803

Search by Drug Name or NDC

NDC 36800-0186-63 TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 20; 70; 50 mg/g; mg/g; mg/g Details

TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 20; 70; 50 mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 36800-0186-63 (36800018663)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c8af028e-9d68-4023-e053-2995a90ad18a Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE:

Do not use

When using this product

Stop use and ask doctor if

Keep out of reach of children.

Directions

Other Information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

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

Search by Drug Name or NDC

NDC 36800-0186-63 TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 20; 70; 50 mg/g; mg/g; mg/g Details

TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 20; 70; 50 mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 36800-0186-63 (36800018663)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c8af028e-9d68-4023-e053-2995a90ad18a Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE:

​Do not use

When using this product

​Stop use and ask doctor if​

​ Keep out of reach of children.

Directions

Other Information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Do not use

Stop use and ask doctor if

Keep out of reach of children.