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NDC 68726-0268-52 Sheet Tint Eye 15 g/100g Details

Sheet Tint Eye 15 g/100g

Sheet Tint Eye is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CP Skin Health Group, Inc.. The primary component is ZINC OXIDE.

Product Information

NDC	68726-0268
Product ID	68726-268_e2989ecb-5a81-6638-e053-2995a90a9e9a
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	Sheet Tint Eye
Proprietary Name Suffix	SPF 30
Non-Proprietary Name	Broad Spectrum
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	15
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	CP Skin Health Group, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	n/a

Package

Package Images

NDC 68726-0268-52 (68726026852)

Pricing Information	N/A
NDC Package Code	68726-268-52
Billing NDC	68726026852
Package	11 g in 1 TUBE (68726-268-52)
Marketing Start Date	2020-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b78c0a02-3fec-cb11-e053-2995a90a64c7 Details

Active ingredient

Zinc Oxide (15%)

Purpose

Sunscreen (UVA & UVB)

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

Stop use and ask a doctor if skin rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swiming or sweating

Reapply at least every two 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 borad spectrum SPF value of 15 or higher and other skin protecting measures including:

- limit time in the sun, epsecially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats and sunglasses

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Acetyl Tetrapeptide-5

Albizia Julibrissin Bark Extract

Arachidyl Alcohol

Arachidyl Glucoside

Behenyl Alcohol

Bisabolol

Butylene Glycol

Butyloctyl Salicylate

Butyrospermum Parkii (Shea Butter)

Capryloyl Glycerin/Sebacic Acid Copolymer

Caprylyl Glycol

Cellulose Gum

Cetearyl Alcohol

Cetyl Alcohol

Citric Acid

Coco-Glucoside

Cocos Nucifera (Coconut) Oil

Darutoside

Diheptyl Succinate

Dimethicone

Dimethicone/Vinyl Dimethicone Crosspolymer

Ethylhexylglycerin

Glycerin

Iron Oxides

Microcrystalline Cellulose

N-Prolyl Palmitoyl Tripeptide-56 Acetate

Octyldodecyl Oleate

Pentylene Glycol

Phenoxyethanol

Polyhydroxystearic Acid

Silica

Sodium Gluconate

Sodium Hyaluronate

Sodium Stearoyl Glutamate

Theobroma Cacao (Cocoa) Seed Butter

Tocopherol

Water

Questions or comments?

877-722-7546

package label

INGREDIENTS AND APPEARANCE

SHEET TINT EYE SPF 30

broad spectrum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68726-268
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
N-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE (UNII: 5YX5BR41EQ)
DARUTOSIDE (UNII: EG8ODI0780)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
COCOA BUTTER (UNII: 512OYT1CRR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
CETYL ALCOHOL (UNII: 936JST6JCN)
DOCOSANOL (UNII: 9G1OE216XY)
SHEA BUTTER (UNII: K49155WL9Y)
COCO GLUCOSIDE (UNII: ICS790225B)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LEVOMENOL (UNII: 24WE03BX2T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68726-268-52	11 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2020	03/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/01/2020	03/31/2023

Labeler - CP Skin Health Group, Inc. (611921669)

Revised: 6/2022

Document Id: e2989ecb-5a81-6638-e053-2995a90a9e9a

Set id: b78c0a02-3fec-cb11-e053-2995a90a64c7

Version: 2

Effective Time: 20220629