Paula's Choice Clear Ultra-Light Daily Hydrating Fluid SPF 30

Paulas Choice Clear Ultra-Light Daily Hydrating Fluid SPF 30 by

Drug Labeling and Warnings

Paulas Choice Clear Ultra-Light Daily Hydrating Fluid SPF 30 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 CLEAR ULTRA-LIGHT DAILY HYDRATING FLUID SPF 30- avobenzone, 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 Clear Ultra-Light Daily Hydrating Fluid SPF 30

Sunscreen

For external use only.

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 mintues before sun exposure. Use a water-resistant sunscreen if swimming or sweating:

Immediately after towel drying

At least every two hours

Children under 6 months: 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 rated SPF 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear a long-sleeve shirt, pants, sunglasses, and a hat.

Protect this product from excessive heat and direct sun. Store at 20-25C (66-77F).

Water, Glycerin, Silica, Dimethicone, Benzyl Alcohol, 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, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Sodium Carbomer, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol

Avobenzone 2.0%

Octinoxate 7.5%

Octisalate 5.0%

Octocrylene 2.0%

PAULAS CHOICE CLEAR ULTRA-LIGHT DAILY HYDRATING FLUID SPF 30 
avobenzone, octinoxate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-613
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 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
DIMETHICONE (UNII: 92RU3N3Y1O)
CHAMOMILE (UNII: FGL3685T2X)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DILL (UNII: Y05PC4JZRH)
OAT BRAN (UNII: KQX236OK4U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CARBONATE (UNII: 45P3261C7T)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-613-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	04/21/2014
2	NDC: 76144-613-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/21/2014

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

Revised: 1/2022

Document Id: c54de183-3159-3b44-e053-2995a90a1deb

34390-5

Set id: b96f9839-a5cd-b356-e053-2995a90aa8cf

Version: 6

Effective Time: 20220106