Paula's Choice Resist Youth-Extending Daily Hydrating Fluid SPF 50

Paulas Choice Resist Youth Extending Daily Hydrating Fluid SPF 50 by

Drug Labeling and Warnings

Paulas Choice Resist Youth Extending Daily Hydrating Fluid 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 RESIST YOUTH EXTENDING DAILY HYDRATING FLUID SPF 50- avonbenzone, octinoxate, octisalate, octocrylene liquid 
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 Resist Youth-Extending Daily Hydrating Fluid SPF 50

Avonbenzone 2.0%

Octinoxate 7.5%

Octisalate 5.0%

Octocrylene 2.0%

Sunscreen

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.

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

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 sunscreen rated 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 of age: ask a doctor

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

Water, Glycerin, Silica, Dimethicone, Tocopherol, Chamomilla Recutita (Matricaria) Flower Extract, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis (Green Tea) Leaf Extract, Camellia Oleifera (Green Tea) Leaf Extract, Peucedanum Graveolens (Dill) Extract, Sambucus Nigra (Black Elderberry) Fruit Extract, Avena Sativa (Oat) Bran Extract, Punica Granatum (Pomegranate) Extract, Lycium Barbarum (Goji) Fruit Extract, Hydrogenated Lecithin, Titanium Dioxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Diethylhexyl Syringylidenemalonate, Potassium Sorbate, Sodium Benzoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Sodium Carbomer, Benzyl Alcohol, Phenoxyethanol

PAULAS CHOICE RESIST YOUTH EXTENDING DAILY HYDRATING FLUID SPF 50 
avonbenzone, octinoxate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-781
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
VITIS VINIFERA SEED (UNII: C34U15ICXA)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
DILL (UNII: Y05PC4JZRH)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
OAT BRAN (UNII: KQX236OK4U)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SODIUM CARBONATE (UNII: 45P3261C7T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHAMOMILE (UNII: FGL3685T2X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-781-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/16/2014
2	NDC: 76144-781-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	07/16/2014
3	NDC: 76144-781-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	07/16/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/16/2014

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

Revised: 1/2022

Document Id: c54e1971-64f1-2d70-e053-2a95a90a6129

34390-5

Set id: 19bf35de-2b1e-439a-e054-00144ff8d46c

Version: 5

Effective Time: 20220106