Label: FACE PLUS SCALP INVISIBLE DAILY SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, and octocrylene gel
- NDC Code(s): 73434-001-30, 73434-001-98
- Packager: Mantl
- 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 August 4, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months of age: Ask a doctor.
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Inactive Ingredients
Isododecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Butyloctyl Salicylate, Epilobium Angustifolium Flower/Leaf/Stem Extract, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Bisabolol, Linoleic Acid, Linolenic Acid, Silica, Water/Aqua/Eau, Sodium Metabisulfite, Phenoxyethanol, Fragrance (Parfum)
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 98 ml Bottle Label
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INGREDIENTS AND APPEARANCE
FACE PLUS SCALP INVISIBLE DAILY SPF 30 BROAD SPECTRUM
avobenzone, homosalate, octisalate, and octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73434-001 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 150 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 28 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) 469.2765 mg in 1 mL DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DICAPRYLYL ETHER (UNII: 77JZM5516Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) LINOLEIC ACID (UNII: 9KJL21T0QJ) LINOLENIC ACID (UNII: 0RBV727H71) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) GINGER (UNII: C5529G5JPQ) TOCOPHEROL (UNII: R0ZB2556P8) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73434-001-98 98 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/05/2020 2 NDC:73434-001-30 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/05/2020 09/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/05/2020 Labeler - Mantl (076670408) Registrant - Cosmetic Lab Inc. (196409143) Establishment Name Address ID/FEI Business Operations Cosmetic Lab Inc. 196409143 manufacture(73434-001, 73434-001)