REDNESS RELIEF PRIMER SPF20- titanium dioxide and zinc oxide lotion

Redness Relief Primer by

Drug Labeling and Warnings

Redness Relief Primer by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., PakLab, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide (3.0%),
Zinc Oxide (8.5%).

Purpose

Sunscreen

Use

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.

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.

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 liberally 30 minutes before sun exposure.
• Reapply at least every two hours.
• Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum 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: ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Cyclopentasiloxane, Isododecane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Caprylyl Methicone, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Cross polymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Water/Aqua/Eau, Polyhydroxystearic Acid, Avena Sativa (Oat) Kernel Oil, Bisabolol, Saccharomyces Lysate Extract, Zingiber Officinale (Ginger) Root Extract, Boerhavia Diffusa Root Extract, Melia Azadirachta Seed Extract, Melia Azadirachta Leaf Extract, Avena Sativa (Oat) Kernel Extract, Amber Powder, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Ocimum Basilicum (Basil) Leaf Extract, Curcuma Longa (Tumeric) Leaf Extract, Pearl Powder, Dodecene, Hydroxyphenyl Propamidobenzoic Acid, Silica Dimethyl Silylate, Dimethicone, Butylene Glycol, Pentylene Glycol, Glycerin, Alumina, PEG-10, Stearic Acid, Triethoxycaprylylsilane, Ethylhexylglycerin, Ascorbyl Palmitate, Potassium Sorbate, Phenoxyethanol, Iron Oxides CI 77492, CI 77499.

Questions or comments?

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

redness
relief
primer

spf
20
broad
spectrum

UVA medium protection

UltraCalming™

0.75 US FL OZ / 22 mL e

dermalogica®

INGREDIENTS AND APPEARANCE

REDNESS RELIEF PRIMER   SPF20
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	30 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	85 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Isododecane (UNII: A8289P68Y2)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer (UNII: O4I3UFO6ZF)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Water (UNII: 059QF0KO0R)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Oat Kernel Oil (UNII: 3UVP41R77R)
Levomenol (UNII: 24WE03BX2T)
Saccharomyces Lysate (UNII: R85W246Z1C)
Ginger (UNII: C5529G5JPQ)
Boerhavia Diffusa Root (UNII: KR0SR09KYL)
Azadirachta Indica Seed (UNII: P1NV46V59R)
Azadirachta Indica Leaf (UNII: HKY915780T)
Oat (UNII: Z6J799EAJK)
Amber (UNII: 70J9Z0J26P)
Coccinia Grandis Fruit (UNII: VLJ6WOT3K5)
Eggplant (UNII: W5K7RAS4VK)
Basil (UNII: 2U0KZP0FDW)
Curcuma Longa Leaf (UNII: H2HC4RY52C)
Pearl (Hyriopsis Cumingii) (UNII: A75L5FZ40U)
Dodecene (UNII: WYE669F3GR)
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Pentylene Glycol (UNII: 50C1307PZG)
Glycerin (UNII: PDC6A3C0OX)
Aluminum Oxide (UNII: LMI26O6933)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
Stearic Acid (UNII: 4ELV7Z65AP)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Ethylhexylglycerin (UNII: 147D247K3P)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-009-02	1 in 1 CARTON
1		22 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-009-00	2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	03/21/2014

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(68479-009)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-009)