LEADER ULTRA SHEER SPF 100 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Purpose

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:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

children under 6 months of age: ask a doctor

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 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

Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, styrene/acylates copolymer, cyclopentasiloxane, silica, beeswax, glyceryl stearate, PEG-100 stearate, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, ethylhexylglycerin, tocopheryl acetate, caprylyl glycol, dipotassium glycyrrhizate, disodium EDTA, triethanolamine, phenoxyethanol, fragrance.

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Leader Ultra Sheer SPF 100 Sunscreen Lotion

3 FL OZ (89 mL)

NDC: 70000-0535-1

INGREDIENTS AND APPEARANCE

LEADER  ULTRA SHEER SPF 100 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0535
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	100 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
TROLAMINE (UNII: 9O3K93S3TK)
YELLOW WAX (UNII: 2ZA36H0S2V)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0535-1	89 mL in 1 TUBE; Type 0: Not a Combination Product	12/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/03/2019

Labeler - CARDINAL HEALTH, INC. (097537435)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(70000-0535)