TINTED MOISTURIZER SPF-20- titanium dioxide, zinc oxide lotion 
HATCHBEAUTY PRODUCTS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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. 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

Oil-Free Tinted Moisturizer_outer

Oil-Free Tinted Moisturizer_inner

TINTED MOISTURIZER  SPF-20
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69863-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.30 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.90 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69863-102-511 in 1 BOX
1NDC:69863-102-1150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/18/2015
Labeler - HATCHBEAUTY PRODUCTS LLC (044612361)
Registrant - HATCHBEAUTY PRODUCTS LLC (044612361)

Revised: 6/2015
Document Id: 19889dd4-43a9-4be7-9666-0d2a7eff8744
Set id: 631ce290-45af-485f-84a3-3b39a11eaedb
Version: 1
Effective Time: 20150625
 
HATCHBEAUTY PRODUCTS LLC