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NDC 69842-0539-66 CVS Health SPF 55 Ultra Sheer Face Mist 300; 1000; 500; 1000 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details

CVS Health SPF 55 Ultra Sheer Face Mist 300; 1000; 500; 1000 mg/10mL; mg/10mL; mg/10mL; mg/10mL

CVS Health SPF 55 Ultra Sheer Face Mist is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	69842-0539
Product ID	69842-539_dfb56532-6f74-1e4d-e053-2a95a90a1c05
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	CVS Health SPF 55 Ultra Sheer Face Mist
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	300; 1000; 500; 1000
Active Ingredient Units	mg/10mL; mg/10mL; mg/10mL; mg/10mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	CVS Pharmacy
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 69842-0539-66 (69842053966)

Pricing Information	N/A
NDC Package Code	69842-539-66
Billing NDC	69842053966
Package	100 mL in 1 CAN (69842-539-66)
Marketing Start Date	2020-11-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dfb55b46-e88f-4949-e053-2995a90adabc Details

Active ingredients

Avobenzone 3.0%,

Homosalate 10.0%,

Octisalate 5.0%,

Octocrylene 10.0%

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.

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

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

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

• hold can 4-6 inches away from skin to apply

Do not apply in windy conditions

• 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

Inactive ingredients

alcohol denat.,dimethicone, trisiloxane, fragrance, diisopropyl adipate, acrylates/octylacrylamide copolymer, acrylates/dimethicone copolymer, tocopherol acetate

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS HEALTH SPF 55 ULTRA SHEER FACE MIST

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-539
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	300 mg in 10 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1000 mg in 10 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	500 mg in 10 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1000 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
TRISILOXANE (UNII: 9G1ZW13R0G)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-539-66	100 mL in 1 CAN; Type 0: Not a Combination Product	11/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/13/2020

Labeler - CVS Pharmacy (062312574)

Revised: 5/2022

Document Id: dfb56532-6f74-1e4d-e053-2a95a90a1c05

Set id: dfb55b46-e88f-4949-e053-2995a90adabc

Version: 1

Effective Time: 20220523

Search by Drug Name or NDC

NDC 69842-0539-66 CVS Health SPF 55 Ultra Sheer Face Mist 300; 1000; 500; 1000 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details

CVS Health SPF 55 Ultra Sheer Face Mist 300; 1000; 500; 1000 mg/10mL; mg/10mL; mg/10mL; mg/10mL

Product Information

Package

Package Images

NDC 69842-0539-66 (69842053966)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dfb55b46-e88f-4949-e053-2995a90adabc 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

Inactive ingredients

Other Information

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

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Search by Drug Name or NDC

NDC 69842-0539-66 CVS Health SPF 55 Ultra Sheer Face Mist 300; 1000; 500; 1000 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details

CVS Health SPF 55 Ultra Sheer Face Mist 300; 1000; 500; 1000 mg/10mL; mg/10mL; mg/10mL; mg/10mL

Product Information

Package

Package Images

NDC 69842-0539-66 (69842053966)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dfb55b46-e88f-4949-e053-2995a90adabc 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

Inactive ingredients

Other Information

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Do not use

Stop use and ask doctor if

Keep out of reach of children.