Cardinal Health Leader General Protection Sunscreen SPF 50 Lotion

Manufacturer
CARDINAL HEALTH, INC.
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:29

Key Label Information

Active Ingredients And Purpose

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use

• on damaged or broken skin.

Stop use and ask a doctor if

• rash occurs.

Directions And Dosage

Directions

• apply liberally and evenly 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 Label Information

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, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, sorbitan isostearate, benzyl alcohol, fragrance

Label

Cardinal Health Leader General Protection Sunscreen SPF 50 Lotion 8 fl oz (237 mL) NDC 70000-0075-1

Label Images

CL14045 Front
CL14045 Front
CL14045 Back
CL14045 Back

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

• rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally and evenly 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, sorbitan isostearate, benzyl alcohol, fragrance

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cardinal Health Leader General Protection Sunscreen SPF 50 Lotion 8 fl oz (237 mL) NDC 70000-0075-1

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc44fc8abb-3479-8a78-e063-6394a90a1368.xml2025-12-04
otc251573e1-f9bd-08ea-e063-6394a90a29ce.xml2024-10-24
otcecb04a97-493b-b148-e053-2995a90abf15.xml2022-11-05
otcb623defb-4a9e-6fc5-e053-2995a90ae846.xml2020-12-11
otcCL14045 Back.jpg2020-12-11
otcCL14045 Front.jpg2020-12-11