FACE PLUS SCALP INVISIBLE DAILY SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, and octocrylene gel 
Mantl

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.

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Face + Scalp Invisible Daily SPF 30 Broad Spectrum

Drug Facts

Active IngredientPurpose
Avobenzone 3%Sunscreen
Homosalate 15%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 2.8%Sunscreen

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

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 15 minutes before sun exposure
  • Reapply at least every 2 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 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.

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

Protect this product from excessive heat and direct sun.

Dist. by Mantl, Inc.
Tustin, CA 92780

PRINCIPAL DISPLAY PANEL - 98 ml Bottle Label

MANTL

FACE + SCALP

Invisible
Daily SPF 30

BROAD SPECTRUM

3.3 fl oz / 98 ml

Principal Display Panel - 98 ml Bottle Label
FACE PLUS SCALP INVISIBLE DAILY SPF 30 BROAD SPECTRUM 
avobenzone, homosalate, octisalate, and octocrylene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73434-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE28 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73434-001-9898 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2020
2NDC:73434-001-3030 mL in 1 TUBE; Type 0: Not a Combination Product01/05/202009/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/05/2020
Labeler - Mantl (076670408)
Registrant - Cosmetic Lab Inc. (196409143)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Lab Inc.196409143manufacture(73434-001, 73434-001)

Revised: 8/2023
 
Mantl