INVISIBLE PHYSICAL DEFENSE SPF30- zinc oxide lotion

INVISIBLE PHYSICAL DEFENSE SPF30 by

Drug Labeling and Warnings

INVISIBLE PHYSICAL DEFENSE SPF30 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide (20.9%)

Purpose

Sunscreen

Uses

• 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

Water/Aqua/Eau, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Dimethicone, Butylene Glycol, Glycerin, Caprylyl Methicone, Silica, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Octyldodecanol, Sodium Chloride, Cordyceps Sinensis Extract, Poria Cocos Sclerotium Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lavandula Hybrida Oil, Tocopheryl Acetate, PEG-10 Dimethicone, Pentylene Glycol, Caprylyl Glycol, Ethylhexylglycerin, Bisabolol, Sodium Hyaluronate, Xylose, Dimethicone Crosspolymer, Sorbitan Olivate, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Eucalyptol, Xanthan Gum, Tocopherol, Sodium Citrate, Sodium Hydroxide, Propanediol, Stearalkonium Hectorite, Propylene Carbonate, Potassium Sorbate, Sodium Benzoate, Linalool, Limonene.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

dermalogica

invisible
physical
defense

SPF
30
FPS

broad spectrum

weightless
physical
sunscreen

Aust L 335173

1.7 US FL OZ / 50 mL e

INGREDIENTS AND APPEARANCE

INVISIBLE PHYSICAL DEFENSE SPF30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-991
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
Argan Oil (UNII: 4V59G5UW9X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Octyldodecanol (UNII: 461N1O614Y)
Sodium Chloride (UNII: 451W47IQ8X)
Sorbitan Olivate (UNII: MDL271E3GR)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
Pentylene Glycol (UNII: 50C1307PZG)
Propanediol (UNII: 5965N8W85T)
Octyldodecyl Xyloside (UNII: 8Z6VNR46QM)
Peg-30 Dipolyhydroxystearate (4000 Mw) (UNII: 9713Q0S7FO)
Stearalkonium Hectorite (UNII: OLX698AH5P)
Caprylyl Glycol (UNII: 00YIU5438U)
Xanthan Gum (UNII: TTV12P4NEE)
Ophiocordyceps Sinensis (UNII: 8Q1GYP08KU)
FU LING (UNII: XH37TWY5O4)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Ethylhexylglycerin (UNII: 147D247K3P)
Propylene Carbonate (UNII: 8D08K3S51E)
Lavandin Oil (UNII: 9RES347CKG)
Levomenol (UNII: 24WE03BX2T)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Eucalyptol (UNII: RV6J6604TK)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Hydroxide (UNII: 55X04QC32I)
Xylose (UNII: A1TA934AKO)
Lavandula Angustifolia Subsp. Angustifolia Flower (UNII: 19AH1RAF4M)
Tocopherol (UNII: R0ZB2556P8)
Linalool, (+/-)- (UNII: D81QY6I88E)
Limonene, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-991-02	1 in 1 CARTON	01/01/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-991-04	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2022
3	NDC: 68479-991-05	7 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2022
4	NDC: 68479-991-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2022

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-991)