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NDC 68726-0269-53 sheer tint 8; 8.1 g/100mL; g/100mL Details

sheer tint 8; 8.1 g/100mL; g/100mL

sheer tint 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 TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	68726-0269
Product ID	68726-269_e2ab89ff-8f1b-5a39-e053-2995a90a91ec
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	sheer tint
Proprietary Name Suffix	SPF 45
Non-Proprietary Name	Broad Spectrum
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	8; 8.1
Active Ingredient Units	g/100mL; g/100mL
Substance Name	TITANIUM DIOXIDE; 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	2023-12-31

Package

Package Images

NDC 68726-0269-53 (68726026953)

Pricing Information	N/A
NDC Package Code	68726-269-53
Billing NDC	68726026953
Package	192 mL in 1 BOTTLE (68726-269-53)
Marketing Start Date	2021-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7c5cedd-ff68-74de-e053-2a95a90a3796 Details

Active Ingredients

Titanium Dioxide (7.6%)

Zinc Oxide (8.0%)

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

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

Reapply:

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

Children under 6 montha: 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 skin protecting 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 this product from excessive heat and direct sun.

Questions?

Please call 877-722-7546

Inactive Ingredients

Alumina

Butyloctyl Salicylate

C12-15 Alkyl Benzoate

Caprylyl Glycol

Dimethicone

Dimethicone/PEG-10/15 Crosspolymer

Dimethicone/Vinyl Dimethicone Crosspolymer

Ethylhexylglycerin

Hexylene Glycol

Hydrogen Dimethicone

Iron Oxides

Isododecane

Jojoba Esters

Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer

Octyldodecanol

PEG-9 Polydimethylsiloxyethyl Dimethicone

Phenoxyethanol

Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone

Polymethylsilsesquioxane

Sodium Chloride

Triethoxycaprylylsilane

Trihydroxystearin

Water

package label

INGREDIENTS AND APPEARANCE

SHEER TINT SPF 45

broad spectrum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68726-269
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.1 g in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
ISODODECANE (UNII: A8289P68Y2)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68726-269-11	177 mL in 1 CAN; Type 0: Not a Combination Product	05/01/2020
2	NDC:68726-269-53	192 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2021

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

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

Revised: 6/2022

Document Id: e2ab89ff-8f1b-5a39-e053-2995a90a91ec

Set id: b7c5cedd-ff68-74de-e053-2a95a90a3796

Version: 3

Effective Time: 20220630