Paula's Choice Extra Care Non-Greasy Sunscreen SPF 50

Paulas Choice Extra Care Non-Greasy Sunscreen SPF 50 by

Drug Labeling and Warnings

Paulas Choice Extra Care Non-Greasy Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Paula's Choice, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAULAS CHOICE EXTRA CARE NON-GREASY SUNSCREEN SPF 50- homosalate, oxybenzone, octisalate, avobenzone, octocrylene 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 Extra Care Non-Greasy Sunscreen SPF 50

Homosalate 10.0%

Oxybenzone 6.0%

Octisalate 5.0%

Avobenzone 3.0%

Octocrylene 2.0%

Sunscreen

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

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 immediately.

Do not use on damaged or broken skin.

Ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

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

Stop use and ask a doctor if rash occurs.

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes of swimming or sweating

-Immediately after towel drying

-At least every 2 hours.

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 sunscreen rated SPF 25 or greater 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 snglasses.

children under 6 months: Ask a doctor.

Children under 6 months: Ask a doctor.

Other Information

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

Inactive Ingredients: Water, Butylene Glycol, PEG-8, Polyethylene, Dimethicone, Silica, Picea Abies (Spruce) Wood Extract, sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Titanium Dioxide, Aloe Barbadensis Leaf Juice, Bentonite, Methyl Glycose Sesquistearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polacrylate, Kaolin, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol

PAULAS CHOICE EXTRA CARE NON-GREASY SUNSCREEN SPF 50 
homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PICEA ABIES WOOD (UNII: 72GZ8K8996)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
BENTONITE (UNII: A3N5ZCN45C)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
KAOLIN (UNII: 24H4NWX5CO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-232-01	148 mL in 1 TUBE; Type 0: Not a Combination Product	08/07/2008
2	NDC: 76144-232-03	3.5 mL in 1 PACKET; Type 0: Not a Combination Product	08/07/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/07/2008

Labeler - Paula's Choice, LLC (029583981)

Revised: 1/2022

Document Id: c54df1c4-712c-bc46-e053-2995a90ab473

34390-5

Set id: b973230d-1ee0-6564-e053-2995a90afb0b

Version: 5

Effective Time: 20220106