TINTED MOISTURIZER SPF-20- titanium dioxide, zinc oxide lotion

TINTED MOISTURIZER by

Drug Labeling and Warnings

TINTED MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by HATCHBEAUTY PRODUCTS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 6.30%

Zinc Oxide 5.90%

PURPOSE

Sunscreen

USE

Helps prevent sunburn

WARNINGS

Warning
For external use only.
Do not use on damaged or broken skin

WHEN USING THIS PRODUCT

When using this product

Keep out of eyes. Rinse with water to remove.

STOP USE AND ASK DOCTOR

Stop use and ask doctor

If rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

Directions

Apply generously to face 15 minutes before sun exposure.

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.

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

wear long-sleeved shirts, pants, hats and sunglasses

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating; immediately after towel drying

INACTIVE INGREDIENTS

Water, Dimethicone, Isododecane, HDI/PPG/Polycaprolactone Crosspolymer, Cyclopentasiloxane, Sapindus Mukorossi Fruit Extract, Oenothera Biennis (Evening Primrose) Root Extract, Jasminum Officinale (Jasmine) Flower Extract, Vitis Vinifera (Grape) Seed Extract, Prunus Persica (Peach) Fruit Extract, Amaranthus Caudatus Extract, Hyaluronic Acid, Tocopherol, Sea Salt, Glycerin, Silica, Isopentyldiol, Pentylene Glycol, Triethoxycaprylylsilane, Disteardimonium Hectorite, Caesalpinia Spinosa Gum, PEG-10 Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disodium EDTA, Phenoxyethanol. (May Contain): Titanium Dioxide (CI 77891), Iron Oxides (CI 77491/77492/77499).

OTHER INFORMATION

Other Information

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER  SPF-20
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69863-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.30 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.90 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
HEXAMETHYLENE DIISOCYANATE (UNII: 0I70A3I1UF)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
OENOTHERA BIENNIS ROOT (UNII: SL194W0S0F)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
PEACH (UNII: 3OKE88I3QG)
AMARANTHUS CAUDATUS WHOLE (UNII: 2Y737E1433)
HYALURONIC ACID (UNII: S270N0TRQY)
TOCOPHEROL (UNII: R0ZB2556P8)
SEA SALT (UNII: 87GE52P74G)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69863-102-51	1 in 1 BOX
1	NDC: 69863-102-11	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/18/2015

Labeler - HATCHBEAUTY PRODUCTS LLC (044612361)

Registrant - HATCHBEAUTY PRODUCTS LLC (044612361)