SMOOTHING MINERAL PRIMER SPF-15- titanium dioxide lotion

SMOOTHING MINERAL PRIMER by

Drug Labeling and Warnings

SMOOTHING MINERAL PRIMER 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 6.90%

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMOOTHING MINERAL PRIMER  SPF-15
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69863-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.90 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69863-101-51	1 in 1 BOX
1	NDC: 69863-101-11	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 69863-101-12	5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69863-101-13	7 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)