Active Ingredients
Octocrylene 10%
Avobenzone 3%
Spf-15 Sunscreen
FDA Label NDC 49794-048
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Continental Manufacturing Chemist, Inc. for the product Spf-15 Sunscreen (NDC 49794-048). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, purpose, do not use, stop use and ask a doctor if, keep out of reach of children, ask a doctor, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Helps Prevent Sunburn
Purpose
Helps prevent sunburn
Do Not Use
in eyes, if this happens rinse thoroughly with water.
Stop Use And Ask A Doctor If
if skin irritation develops
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center
Ask A Doctor
before using on children under 6 months
Directions
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reaaply at least every 2 hours
Storage
Store at 20-25C (68-77F)
Inactive Ingredients
Aloe Barbadensis (Aloe Vera) Gel, Benzyl Alcohol, Carbopol, Cetyl Alcohol, Fragrance, (Glyceryl Stearate and PEG 100 Stearate), Methyl Paraben, PEG-40 Stearate, Phenoxyethanol, (Polyacrylamide and C13-14 Isoparrafin and Laureth-7), Propyl Paraben, Purified Water, Shea Butter, Sodium Hydroxide, Sorbitan Monooleate, Stearic Acid, Tetrasodium Ethylenediaminetatraacetate, Vitamin E
Principal Display Panel
Product
Spf-15 Labels (Broad Spectrum Spf 15 Sunscreen Lotion 1)
Manufactured By
Continental Manufacturing Chemist, Inc.
912 S. State Street, Madrid, IA 50156
* Please review the disclaimer below.
