Active Ingredient
Octinoxate 6.00%
Zinc oxide 2.00%
Sudden Change Derma Renewal Complex
FDA Label NDC 61543-0003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cca Industries Inc. for the product Sudden Change Derma Renewal Complex (NDC 61543-0003). 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 ingredient, purpose, uses:, warnings, do not use, when using this product, stop use and ask a doctor, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses:
Hepls prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
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 The Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- For sunsreen use: apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor.
Other Information
- Protect this product from excessive heat and direct sun.
Inactive Ingredients
WATER (AQUA), BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, SIMMONDSIA, CHINENSIS (JOJOBA) SEED OIL, GLYCERIN, DIMETHICONE, CETEARYL OLIVATE, HYDROGENATED OLIVE OIL, UNSAPONIFIABLES, CETYL ALCOHOL, SORBITAN OLIVATE, ALOE BARBADENSIS LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE, SODIUM HYALURONATE, C12-15 ALKYL BENZOATE, TRIBEHENIN, CERAMIDE NG, PEG-10 RAPESEED STEROL, PALMITOYL HEXAPEPTIDE-12, XANTHAN GUM, ALLANTOIN, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, CAPRYLYL GLYCOL, POTASSIUM SORBATE, HEXYLENE GLYCOL, BISABOLOL, FRAGRANCE, CITRUS AURANTIUM (NEROLI) FLOWER OIL
Questions Or Comments?
Call 1-800-595-6230
Report any issues associated with this product to the telephone number or address listed on this package.
Package Labeling:
Label4 (Label4)
* Please review the disclaimer below.
