RODAN AND FIELDS PLUMPING LIP SPF 28 SUNSCREEN- octinoxate, zinc oxide oil

Rodan and Fields Plumping Lip SPF 28 Sunscreen by

Drug Labeling and Warnings

Rodan and Fields Plumping Lip SPF 28 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.4%

Zinc Oxide 7%

Purpose

Sunscreen

Uses

• helps prevent sunburn.

Warnings Skin Cancer/ Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

Directions

• apply generously, covering lips completely at least 15 minutes before sun exposure.

Do not apply outside of lip lines.

• reapply at least every 2 hours.
• use a water resistant sunscreen if swimming or sweating.
• children under 6 months of age: Ask a doctor.

Other Information

• Protect this product from excessive heat and direct sun. Store between 59-86°F.

Inactive ingredients:

Hydrogenated Polyisobutene, Phenyl Trimethicone, Ethylhexyl Palmitate, Dextrin Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glyceryl Behenate, Disteardimonium Hectorite, Dipalmitoyl Hydroxyproline, BHT, C10-18 Triglycerides, Calcium Sodium Borosilicate, Capsicum Annuum Extract (Fruit), Glyceryl Dioleate, Menthol, Lactic Acid, Linoleic Acid, Linolenic Acid, Octyldodecanol, Oleic Acid, Palmitic Acid, Palmitoyl Tripeptide-1, Polyhydroxystearic Acid, Sodium Hyaluronate, Sorbitan Isostearate, Sorbitan Oleate, Stearic Acid, Synthetic Fluorphlogopite, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Tribehenin, Triolein,+/-: Blue 1 Lake (Cl 42090), Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Red 6 (Cl 15850), Yellow 5 Lake (Cl 19140).

Questions?

1-888-995-5656

Principal Display Panel – 5 mL Carton Label

RODAN + FIELDS

Plumping Lip Oil

SPF 28

Sunscreen

5 mL/0.17 FL. Oz. U.S.

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS PLUMPING LIP SPF 28 SUNSCREEN 
octinoxate, zinc oxide oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-3000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.4 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Hydrogenated Polyisobutene (1300 MW) (UNII: 7D1YQ9Y5EZ)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Ethylhexyl Palmitate (UNII: 2865993309)
Dextrin Palmitate (Corn; 20000 MW) (UNII: 89B2BSF9I3)
Sunflower Oil (UNII: 3W1JG795YI)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Glyceryl Monobehenate (UNII: A626UU0W2A)
Disteardimonium Hectorite (UNII: X687XDK09L)
Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
C10-18 Triglycerides (UNII: 43AGM4PHPI)
Calcium Sodium Borosilicate (UNII: 4MM76N4WMY)
Glyceryl Dioleate (UNII: Z3MP1W91CW)
Menthol (UNII: L7T10EIP3A)
Lactic Acid (UNII: 33X04XA5AT)
Linoleic Acid (UNII: 9KJL21T0QJ)
Linolenic Acid (UNII: 0RBV727H71)
Octyldodecanol (UNII: 461N1O614Y)
Oleic Acid (UNII: 2UMI9U37CP)
Palmitic Acid (UNII: 2V16EO95H1)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Stearic Acid (UNII: 4ELV7Z65AP)
Magnesium Potassium Aluminosilicate Fluoride (UNII: YK3DC63Y5M)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Tocopherol (UNII: R0ZB2556P8)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tribehenin (UNII: 8OC9U7TQZ0)
Glyceryl Trioleate (UNII: O05EC62663)
FD&C Blue No. 1 Aluminum Lake (UNII: J9EQA3S2JM)
Ferric Oxide Red (UNII: 1K09F3G675)
D&C Red No. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Capsicum (UNII: 00UK7646FG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-3000-1	1 in 1 BOX	05/16/2024
1		5 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 14222-3000-2	1 in 1 BOX	05/16/2024
2		5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 14222-3000-3	1 in 1 BOX	05/16/2024
3		5 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 14222-3000-4	1 in 1 BOX	05/16/2024
4		5 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 Drug	M020	05/16/2024

Labeler - Rodan & Fields (051659584)