PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 by

Drug Labeling and Warnings

PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Paula's Choice, Inc, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAULA'S CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30

Active Ingredients

Titanium Dioxide 2.32%
Zinc Oxide 6.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  

Warnings

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 rash occurs.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

• apply liberally 15 minutes before sun exposure
• use a water-resistant sunscreen if swimming or sweating.
• reapply at least every two hours if skin exposed to sun.
• 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 of 15 or higher and other sun protection measures including:
• • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months:  Ask a doctor
  

Other Information

• protect this product from excessive heat and direct sun
• you may report serious and adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057
  

Inactive Ingredients

Water, Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Polysorbate 80, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomila Recutita (Matricaria) Flower Extract, Algae Extract, Aloe Barbadensis Leaf Juice, Allantoin, Glycerin, Panthenol, Butylene Glycol, Caprylyl Glycol, Alumina, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Disodium EDTA, Chlorphenesin, Phenoxyethanol.

What it does:

    * Light lotion leaves soft, matte finish
    * Great for sensitive skin and rosacea
    * Prevents signs of aging

"Make sun protection an every day habit like brushing your teeth."  Paula Begour   Clinically proven non-irritating.  100% fragrance free.  No added dyes.  No animal testing.  Made in USA.  Manufactured for Paula's Choice, Inc. Seattle, WA 98057.  Paula's Choice is a registered trademark of Paula's Choice, Inc.  1.800.831.4088  (U.S. and Canada)  PaulasChoice.com

PRINCIPAL DISPLAY PANEL

PAULA'S CHOICE   HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX  Broad Spectrum SPF 30 Normal  Oily  Combination with Antioxidants  moisturizer + spf   60 ml / 2 fl. oz.

PAULA'S CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 60ml (

76144-000-00)

INGREDIENTS AND APPEARANCE

PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.2 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-000-00	1 in 1 CARTON	12/19/2017
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/11/2013

Labeler - Paula's Choice, Inc (029583981)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76144-000)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76144-000)