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NDC 69842-0466-09 CVS Health SPF 50 Zinc Sheer Sunscreen 216 mg/mL Details

CVS Health SPF 50 Zinc Sheer Sunscreen 216 mg/mL

CVS Health SPF 50 Zinc Sheer Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY. The primary component is ZINC OXIDE.

Product Information

NDC	69842-0466
Product ID	69842-466_d501dcd9-2c84-c860-e053-2a95a90a2062
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 50 Zinc Sheer Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	216
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	CVS PHARMACY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0466-09 (69842046609)

Pricing Information	N/A
NDC Package Code	69842-466-09
Billing NDC	69842046609
Package	89 mL in 1 TUBE (69842-466-09)
Marketing Start Date	2017-12-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d5017620-983a-b372-e053-2995a90af0e2 Details

Active ingredient

Zinc Oxide 21.6%

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

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

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

apply liberally 15 minutes before sun exposure

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

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octydodecyl citrate crosspolmyer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, glycerin, polyhydroxystearic acid, ethyl methicone, cetyl dimethicone, silica, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, bis-divinyl dimethicone/PEG-10 dimethicone crosspolymer, sodium chloride, phenoxyethanol, chlorphenesin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS HEALTH SPF 50 ZINC SHEER SUNSCREEN

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-466
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	216 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
WATER (UNII: 059QF0KO0R)
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-466-09	89 mL in 1 TUBE; Type 0: Not a Combination Product	12/04/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	12/04/2017

Labeler - CVS PHARMACY (062312574)

Revised: 1/2022

Document Id: d501dcd9-2c84-c860-e053-2a95a90a2062

Set id: d5017620-983a-b372-e053-2995a90af0e2

Version: 2

Effective Time: 20220107