OTC Medication Information: Leader General Protection SPF 30 Sunscreen

LEADER GENERAL PROTECTION SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion
CARDINAL HEALTH, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
Octocrylene 10.0%

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
S un 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, ethylhexyl palmitate, polyamide-8, benzyl alcohol, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, retinyl palmitate, oleth-3, disodium EDTA

CL13535E1-F1
(click image for full-size original)

LEADER GENERAL PROTECTION SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0536
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SORBITOL
TROLAMINE
ETHYLHEXYL PALMITATE
POLYAMIDE-8 (4500 MW)
DIETHYLHEXYL SYRINGYLIDENEMALONATE
BENZYL ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER COPOLYMER TYPE A
CHLORPHENESIN
SODIUM ASCORBYL PHOSPHATE
TOCOPHEROL
VITAMIN A PALMITATE
OLETH-3
EDETATE DISODIUM (EDETIC ACID)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0536-1 237 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/19/2019
Labeler — CARDINAL HEALTH, INC. (063997360)

Revised: 11/2022 CARDINAL HEALTH, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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