Paula's Choice Ultra-Sheer Daily Defense SPF 30

Paulas Choice Ultra Sheer Daily Defense SPF 30 by

Drug Labeling and Warnings

Paulas Choice Ultra Sheer Daily Defense 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 ULTRA SHEER DAILY DEFENSE SPF 30- oxybenzone, avobenzone, octobrylene, homosalate 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 Ultra-Sheer Daily Defense SPF 30

Active Ingredients

Avobenzone 3.0%

Homosalate 7.0%

Octocrylene 2.0%

Oxybenzone 4.0%

Moisturizer and sunscreen

Uses

• Helps prevent sunburn
• Decreases the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures

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 and early skin aging. To decrease this resk regulatly use a sunscreen with a broad-spectrum SPF of 15 or greater and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm. wear a long sleep shirt, pants, sunglasses, and hat. Children under 6 months: Ask a doctor

Warnings

on damaged or broken skin

keep out of eyes. Rinse with water to remove.

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

If rash occurs

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 Ingredient Section

Water

Butylene Glycol

Silica

Camellia Sinensis Leaf Extract

Aloe Barbadensis Leaf Juice Powder

Ascorbyl Palmitate

Phospholipids

Superoxide Dismutase

Adenosine

Tocopherol

Bisabolol

Boerhavia Diffusa Root Extract

Colloidal Oatmeal

Panthenol

Ginkgo Biloba Leaf Extract

Salix Alba (Willow) Bark Extract

Cetyl Dimethicone

Aluminum Starch Octenylsuccinate

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Titanium Dioxide

Sorbic Acid

Sodium Hydroxide

Steareth-21

Steareth-2

Polysorbate 20

Disodium EDTA

Phenoxyethanol

PAULAS CHOICE ULTRA SHEER DAILY DEFENSE SPF 30 
oxybenzone, avobenzone, octobrylene, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADENOSINE (UNII: K72T3FS567)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
STEARETH-2 (UNII: V56DFE46J5)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GINKGO (UNII: 19FUJ2C58T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OATMEAL (UNII: 8PI54V663Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
SORBIC ACID (UNII: X045WJ989B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
SALIX ALBA BARK (UNII: 205MXS71H7)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-156-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	04/03/2013
2	NDC: 76144-156-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	04/03/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/03/2013

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

Revised: 1/2022

Document Id: c54ddd72-5d71-218c-e053-2995a90a7cee

34390-5

Set id: 1318c6e0-aa3d-5968-e054-00144ff8d46c

Version: 4

Effective Time: 20220106