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

Face Plus Scalp Invisible Daily SPF 30 Broad Spectrum by

Drug Labeling and Warnings

Face Plus Scalp Invisible Daily SPF 30 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Mantl, Cosmetic Lab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product 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

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)