![OIL FREE MATTE SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE) LOTION [DERMALOGICA]](https://medic.hrt.org//dailymed/images/c906e203-f31c-44f7-856f-fb1b9bc30e1c/oil-free-matte-01.jpg)
| NDC | 68479-110-00, 68479-110-02 |
| Set ID | c906e203-f31c-44f7-856f-fb1b9bc30e1c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Dermalogica |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- 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
-
Inactive ingredients
Water/Aqua/Eau, PPG-3 Benzyl Ether Ethylhexanoate, Butylene Glycol, Nylon-12, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Stearic Acid, Polysorbate 80, Enantia Chlorantha Bark Extract, Camellia Sinensis Leaf Extract, Oleanolic Acid, Niacinamide, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ammonium Glycyrrhizate, Panthenol, Zinc Gluconate, Caffeine, Biotin, Ascorbyl Tetraisopalmitate, Sodium DNA, Tocopherol, Caprylic/Capric Triglyceride, Carbomer, Carthamus Tinctorius (Safflower) Oleosomes, Citrus Grandis (Grapefruit) Peel Oil, Limonene, Tocopherol Acetate, Behenyl Alcohol, Arachidyl Glucoside, Cetyl Alcohol, Glyceryl Stearate SE, Sorbitan Stearate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Sodium Hydroxide, Disodium EDTA.
- Other information
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
OIL FREE MATTE SPF 30
avobenzone, homosalate, octisalate, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 80 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 40 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PPG-3 Benzyl Ether Ethylhexanoate (UNII: 3N703GY99W) Butylene Glycol (UNII: 3XUS85K0RA) Nylon-12 (UNII: 446U8J075B) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458) Stearic Acid (UNII: 4ELV7Z65AP) Polysorbate 80 (UNII: 6OZP39ZG8H) Annickia Chlorantha Bark (UNII: H70115MP4A) Green Tea Leaf (UNII: W2ZU1RY8B0) Oleanolic Acid (UNII: 6SMK8R7TGJ) Niacinamide (UNII: 25X51I8RD4) Yeast, Unspecified (UNII: 3NY3SM6B8U) Horse Chestnut (UNII: 3C18L6RJAZ) Ammonium Glycyrrhizate (UNII: 3VRD35U26C) Panthenol (UNII: WV9CM0O67Z) Zinc Gluconate (UNII: U6WSN5SQ1Z) Caffeine (UNII: 3G6A5W338E) Biotin (UNII: 6SO6U10H04) Ascorbyl Tetraisopalmitate (UNII: 47143LT58A) Tocopherol (UNII: R0ZB2556P8) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309) Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Cetyl Alcohol (UNII: 936JST6JCN) Glyceryl Stearate SE (UNII: FCZ5MH785I) Sorbitan Monostearate (UNII: NVZ4I0H58X) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) Isohexadecane (UNII: 918X1OUF1E) Polysorbate 60 (UNII: CAL22UVI4M) Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Xanthan Gum (UNII: TTV12P4NEE) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Hydroxide (UNII: 55X04QC32I) Edetate Disodium (UNII: 7FLD91C86K) Docosanol (UNII: 9G1OE216XY) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-110-02 1 in 1 CARTON 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68479-110-00 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 02/16/2012 Labeler - Dermalogica (177698560) Establishment Name Address ID/FEI Business Operations Cosway 620899877 MANUFACTURE(68479-110) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-110)
