PAULAS CHOICE RESIST SMOOTHING PRIMER SERUM SPF 30- avobenzone, homosalate, octinoxate, octisalate gel

Paulas Choice Resist Smoothing Primer Serum SPF 30 by

Drug Labeling and Warnings

Paulas Choice Resist Smoothing Primer Serum 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]

ACTIVE INGREDIENT

Avobenzone, 2.0%
Homosalate, 4.0%
Octinoxate, 6.0%
Octisalate, 4.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases hte risk of skin cancer and early skin aging caused by sun.

WARNINGS

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 swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liverally 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating: Immediately after towl drying. At least every two hours.

Children under 6 months of age: 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 with a broad spectrum SPF of 15 or higher and other sun protetion measures, including: Limit time in the sun, especially from 10am-2pm. Wear long-sleeve shirts, pants, hates and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at 20-25°C (68-77°F).

INACTIVE INGREDIENT

Isododecane, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate,Polysilicone-11, Bisabolol, Coffea Arabica (Coffee) Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Calluna Vulgaris Flower Extract, Camellia Sinensis Leaf Extract, Chlorella Vulgaris Extract, Caprylic/Capric Triglyceride, Physalis Angulata Extract, Pyrus Malus (Apple) Fruit Extract, Diethylhexyl Syringylidenemalonate.

Questions or Comments?

Call 1.800.831.4088 (U.S. and Canada)

Mon-Fri 6am-6pm | Sat-Sun 8am-4:30pm PT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAULAS CHOICE RESIST SMOOTHING PRIMER SERUM SPF 30 
avobenzone, homosalate, octinoxate, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-915
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV)
APPLE (UNII: B423VGH5S9)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LEVOMENOL (UNII: 24WE03BX2T)
LICORICE (UNII: 61ZBX54883)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
CHAMOMILE (UNII: FGL3685T2X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-915-01	1 in 1 CARTON	02/01/2017
1	NDC: 76144-915-00	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

Labeler - Paula's Choice, LLC (029583981)