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NDC 36800-0239-63 TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 30; 100; 50; 50 mg/g; mg/g; mg/g; mg/g Details

TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 30; 100; 50; 50 mg/g; mg/g; mg/g; mg/g

TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	36800-0239
Product ID	36800-239_c8c16050-760f-4038-e053-2995a90aa870
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 CONTINUOUS BROAD SPECTRUM 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; 50
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; 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 36800-0239-63 (36800023963)

Pricing Information	N/A
NDC Package Code	36800-239-63
Billing NDC	36800023963
Package	2 CAN in 1 PACKAGE (36800-239-63) / 156 g in 1 CAN (36800-239-37)
Marketing Start Date	2017-01-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c8c12a5a-59f5-6515-e053-2995a90a58f7 Details

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, 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 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., 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 CONTINUOUS BROAD SPECTRUM SPF 50

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-239
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-239-37	156 g in 1 CAN; Type 0: Not a Combination Product	01/04/2017
2	NDC:36800-239-63	2 in 1 PACKAGE	01/04/2017
2	NDC:36800-239-37	156 g in 1 CAN; Type 0: Not a Combination Product
3	NDC:36800-239-62	3 in 1 PACKAGE	01/04/2017
3	NDC:36800-239-37	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	01/04/2017

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 8/2021

Document Id: c8c16050-760f-4038-e053-2995a90aa870

Set id: c8c12a5a-59f5-6515-e053-2995a90a58f7

Version: 1

Effective Time: 20210804