The Starter Kit by MANTL The Starter Kit

The Starter Kit by

Drug Labeling and Warnings

The Starter Kit by is a Otc medication manufactured, distributed, or labeled by MANTL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THE STARTER KIT- avobenzone, homosalate, octisalate, and octocrylene 
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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The Starter Kit

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 - Kit Box

MANTL

PREMIUM FACE + SCALP SKINCARE
The Starter Kit

Principal Display Panel - Kit Box
THE STARTER KIT 
avobenzone, homosalate, octisalate, and octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73434-002
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73434-002-011 in 1 BOX11/01/202003/12/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 30 mL
Part 21 TUBE 30 mL
Part 31 TUBE 30 mL
Part 41 CASE 1 UNITS
Part 1 of 4
FACE PLUS SCALP INVISIBLE DAILY SPF 30 BROAD SPECTRUM 
avobenzone, homosalate, octisalate, and octocrylene gel
Product Information
Item 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: 73434-001-3030 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2020
Part 2 of 4
FACE PLUS SCALP AGE DEFENSE MOISTURIZER 
moisturizing
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCOCONUT ALKANES (UNII: 1E5KJY107T)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRCETEARYL OLIVATE (UNII: 58B69Q84JO)  
INGRSORBITAN OLIVATE (UNII: MDL271E3GR)  
INGRN-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE (UNII: 5YX5BR41EQ)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
INGRCOCO-CAPRYLATE (UNII: 4828G836N6)  
INGRPentylene Glycol (UNII: 50C1307PZG)  
INGRSodium Metabisulfite (UNII: 4VON5FNS3C)  
INGRCaprylyl Glycol (UNII: 00YIU5438U)  
INGRChlorphenesin (UNII: I670DAL4SZ)  
INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/01/2020
Part 3 of 4
FACE PLUS SCALP CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads)
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
INGRSODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)  
INGRGlycerin (UNII: PDC6A3C0OX)  
INGRSodium Methyl Oleoyl Taurate (UNII: 8PZ076134H)  
INGRCocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
INGRPropanediol (UNII: 5965N8W85T)  
INGRBACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRLauryl Glucoside (UNII: 76LN7P7UCU)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
INGRDehydroacetic Acid (UNII: 2KAG279R6R)  
INGRSodium Benzoate (UNII: OJ245FE5EU)  
INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/01/2020
Part 4 of 4
FACE PLUS SCALP NO-SHINE SHEETS 
cleansing (cold creams, cleansing lotions, liquids, and pads)
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPINUS ARMANDII WOOD (UNII: LZ9XOK71MS)  
INGRPHYLLOSTACHYS EDULIS CHARCOAL (UNII: 3U1L3HHP6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 UNITS in 1 CASE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/202012/03/2021
Labeler - Mantl (076670408)
Registrant - Cosmetic Lab Inc. (196409143)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Lab Inc.196409143manufacture(73434-001, 73434-002)

Revised: 8/2023

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