SMOOTHING MINERAL PRIMER SPF-15- titanium dioxide 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 6.90%

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

Cyclopentasiloxane, Isododecane, Glyceryl Behenate, PEG-10 Dimethicone, Polysilicone-11, Alumina, Water, Methicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Prunus Persica (Peach) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Root Extract, Jasminum Officinale (Jasmine) Extract, Amaranthus Caudatus Seed Extract, Ethylhexylglycerin, Phenoxyethanol.

OTHER INFORMATION

Other Information

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

Label_Smoothing Mineral Primer_outer

Label_Smoothing Mineral Primer_inner

Bliss_Mineral Primer Card_3 5 pdf FINAL_2

SMOOTHING MINERAL PRIMER  SPF-15
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69863-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.90 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ISODODECANE (UNII: A8289P68Y2)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
WATER (UNII: 059QF0KO0R)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
PEACH (UNII: 3OKE88I3QG)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
OENOTHERA BIENNIS ROOT (UNII: SL194W0S0F)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69863-101-511 in 1 BOX
1NDC:69863-101-1130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:69863-101-125 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:69863-101-137 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: 12/2015
Document Id: 99f8dd9f-b9d2-4169-abe8-71850527fab1
Set id: ec3bea36-644d-4263-970c-5e001a257fc7
Version: 4
Effective Time: 20151216
 
HATCHBEAUTY PRODUCTS LLC