Label: INVISIBLE PHYSICAL DEFENSE SPF30- zinc oxide lotion
- NDC Code(s): 68479-991-00, 68479-991-02, 68479-991-04, 68479-991-05
- Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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
-
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
-
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
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
INVISIBLE PHYSICAL DEFENSE SPF30
zinc oxide lotionProduct 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)
