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NDC 74154-0016-06 Kiss My Face Cool Sport 30 Mineral Sunscreen 78 mg/mL Details

Kiss My Face Cool Sport 30 Mineral Sunscreen 78 mg/mL

Kiss My Face Cool Sport 30 Mineral Sunscreen is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Windmill Health Products, LLC. The primary component is TITANIUM DIOXIDE.

Product Information

NDC	74154-0016
Product ID	74154-016_61819350-ff9c-4db5-a59d-af816a286500
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	Kiss My Face Cool Sport 30 Mineral Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	78
Active Ingredient Units	mg/mL
Substance Name	TITANIUM DIOXIDE
Labeler Name	Windmill Health Products, 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 74154-0016-06 (74154001606)

Pricing Information	N/A
NDC Package Code	74154-016-06
Billing NDC	74154001606
Package	177 mL in 1 CAN (74154-016-06)
Marketing Start Date	2022-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 57989817-ddc9-4ccd-ba74-ea04d4e3dd7a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Titanium Dioxide 7.8%

Purpose

Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more sunburn protection
If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.

Warnings

Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F.
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 skin rash or irritation develops and lasts.

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.

Directions

Apply liberally 15 minute before sun exposure.
Hold 4 to 6 inches away from body when spraying.
Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face.
Do not apply in windy conditions.
Use in well-ventilated areas and avoid inhalation.
Reapply:
- after 80 minutes of swimming or sweating,
- immediately after towel drying and
- 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 risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other sun protection measures including:
- Limit time in sun, especially from 10am to 2pm.
- Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol , Coco-Glucoside, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Fragrance (Parfum)1, Ginkgo Biloba Leaf Extract, Glycerin, Heptyl Undecylenate, Impatiens Balsamina (Garden Balsam) Leaf Extract, Methyl Dihydroabietate, Persea Gratissima (Avocado) Fruit Extract, Silica, Tocopherol, Water (Aqua)

1: Natural fragrance

Other Information

Protect this product from excessive heat and direct sun.

Questions?

Call 800-822-4320 Or visit www.kissmyface.com

PRINCIPAL DISPLAY PANEL - 177 ml Can Label

KISS

MY

FACE®

30

cool sport

mineral sunscreen

wet & dry skin formula

broad spectrum SPF30

water resistant (80 minutes)

hydrates & protects

aloe vera

cucumber

REEF FRIENDLY*

6 fl oz (177 ml)

PRINCIPAL DISPLAY PANEL - 177 ml Can Label

INGREDIENTS AND APPEARANCE

KISS MY FACE COOL SPORT 30 MINERAL SUNSCREEN

titanium dioxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74154-016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	78 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENTONITE (UNII: A3N5ZCN45C)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Caprylyl Glycol (UNII: 00YIU5438U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Coco Glucoside (UNII: ICS790225B)
Cucumber (UNII: YY7C30VXJT)
Ethylhexylglycerin (UNII: 147D247K3P)
GINKGO (UNII: 19FUJ2C58T)
Glycerin (UNII: PDC6A3C0OX)
Heptyl Undecylenate (UNII: W77QUB6GXO)
Impatiens Balsamina Leaf (UNII: LH9E1X602V)
Methyl Dihydroabietate (UNII: 7666FJ0J9F)
Avocado (UNII: SDS87L369F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Tocopherol (UNII: R0ZB2556P8)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74154-016-06	177 mL in 1 CAN; Type 0: Not a Combination Product	02/22/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	02/22/2022

Labeler - Windmill Health Products, LLC (831136267)

Name	Address	ID/FEI	Business Operations
Establishment
Bell International Laboratories		967781555	MANUFACTURE(74154-016)

Revised: 2/2022

Document Id: 61819350-ff9c-4db5-a59d-af816a286500

Set id: 57989817-ddc9-4ccd-ba74-ea04d4e3dd7a

Version: 1

Effective Time: 20220217