SKINPERFECT PRIMER SPF30- zinc oxide lotion

SKINPERFECT PRIMER SPF30 by

Drug Labeling and Warnings

SKINPERFECT PRIMER SPF30 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide (25.0%).

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.
• Childen under 6 months: ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Isododecane, Butyloctyl Salicylate, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Titanium Dioxide, Polysilicone-11, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Argania Spinosa Kernel Oil, PEG/PPG-18/18 Dimethicone, Palmitoyl Tripeptide-1, Dipotassium Glycyrrhizate, Hyaluronic Acid, Lavandula Hybrida Oil, Eucalyptol, Lavandula Angustifolia (Lavender) Flower Extract, Tocopheryl Acetate, Sodium PCA, Tocopherol, Bisabolol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Isononyl Isononanoate, Carnosine, Caprylyl Glycol, Silica Silylate, Pentylene Glycol, Laureth-12, Ethylhexylglycerin, Mica, Glycerin, Isopropyl Titanium Triisostearate, Water/Aqua/Eau, Ozokerite, Propanediol, Tin Oxide, Linalool, Limonene, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).

Questions / comments?

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PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

skinperfect
primer

SPF
30

high
protection

UVA
UVB
broad spectrum

smoothing +
illuminating
tinted primer

Daily Skin Health

0.75 US FL OZ / 22 mL ℮

dermalogica

INGREDIENTS AND APPEARANCE

SKINPERFECT PRIMER SPF30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	24.96 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Isododecane (UNII: A8289P68Y2)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
Titanium Dioxide (UNII: 15FIX9V2JP)
ARGAN OIL (UNII: 4V59G5UW9X)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
Water (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
Mica (UNII: V8A1AW0880)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVANDIN OIL (UNII: 9RES347CKG)
LEVOMENOL (UNII: 24WE03BX2T)
CERESIN (UNII: Q1LS2UJO3A)
Pentylene Glycol (UNII: 50C1307PZG)
Propanediol (UNII: 5965N8W85T)
Carnosine (UNII: 8HO6PVN24W)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Caprylyl Glycol (UNII: 00YIU5438U)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)
Ethylhexylglycerin (UNII: 147D247K3P)
SODIUM PIDOLATE (UNII: 1V74VH163T)
Laureth-12 (UNII: OAH19558U1)
Hyaluronic Acid (UNII: S270N0TRQY)
Eucalyptol (UNII: RV6J6604TK)
STANNIC OXIDE (UNII: KM7N50LOS6)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
Tocopherol (UNII: R0ZB2556P8)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-132-02	1 in 1 CARTON	12/02/2022
1		22 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-132-01	1 in 1 CARTON	12/02/2022
2		7 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68479-132-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	12/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	12/02/2022

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-132)