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NDC 70000-0016-01 Leader 30; 130; 50; 70; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

Leader 30; 130; 50; 70; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

Leader is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH, INC.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	70000-0016
Product ID	70000-0016_ecaf88a1-a3fc-6306-e053-2a95a90af778
Associated GPIs	90920000004100
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Leader
Proprietary Name Suffix	Baby SPF 50
Non-Proprietary Name	avobenzone, homosalate, octisalate, octocrylene, oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 130; 50; 70; 40
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	CARDINAL HEALTH, INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0016-01 (70000001601)

Pricing Information	N/A
NDC Package Code	70000-0016-1
Billing NDC	70000001601
Package	237 mL in 1 BOTTLE (70000-0016-1)
Marketing Start Date	2019-10-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62e190aa-3573-44f5-bced-614bc1171e12 Details

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.

Stop use and ask a doctor if

• rash occurs.

When using this product keep out of eyes.

Rinse with water to remove

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-sleeved 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

Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 11/2022

Document Id: ecaf88a1-a3fc-6306-e053-2a95a90af778

Set id: 62e190aa-3573-44f5-bced-614bc1171e12

Version: 4

Effective Time: 20221104