Paulas Choice Hydralight Shine Free Daily Mineral Complex by Paula's Choice, LLC. Paula's Choice

Drug Details [pdf]

PAULAS CHOICE HYDRALIGHT SHINE FREE DAILY MINERAL COMPLEX- titanium dioxide, zinc oxide lotion
Paula's Choice, 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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Paula's Choice

Titanium Dioxide 2.32%

Zinc Oxide 6.0%

Sunscreen

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.

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

Directions

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every two hours if skin is 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 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

Protect this product from excessive heat and direct sun. You may report serious adverse reaction to 705 5th Avenue, South, Suite 200, Seattle, WA 98104

Water, Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Polysorbate 80, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Sodium Acrylate/Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla 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, Triethoxyxaprylylsilane, Disodium EDTA, Chlorphenesin, Phenoxyethanol

Full

PAULAS CHOICE HYDRALIGHT SHINE FREE DAILY MINERAL COMPLEX
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-172
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 76144-172-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/15/2011
2	NDC: 76144-172-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	08/15/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/15/2011

Labeler - Paula's Choice, LLC. (029583981)

Revised: 1/2022

Document Id: c54e1ebf-6283-d294-e053-2995a90a96cb

Set id: 19b0d330-89b8-51cf-e054-00144ff88e88

Version: 4

Effective Time: 20220106