LEADER BABY SPF 50- 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 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

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 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-sleeve shirts, pants, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun



may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol acetate (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Leader Baby SPF 50 Lotion

8 FL OZ (237 mL)

NDC: 70000-0016-1

INGREDIENTS AND APPEARANCE

LEADER  BABY SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	130 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITOL (UNII: 506T60A25R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0016-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/30/2019

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(70000-0016)