Skip to content

Checked

OTC

CLE CCC Warm Light

titanium dioxide, octinoxate, octisalate · CLE CCC Warm Light is an over-the-counter drug containing titanium dioxide, octinoxate, octisalate, made by KW ABSC, INC..

Type
Over the counter
Drug class
Not classified
Route
Topical
Manufacturers
1

Helps prevent sunburn

Drug facts

Generic name
titanium dioxide, octinoxate, octisalate
Active ingredients
Octinoxate, Octisalate, Titanium Dioxide
Dosage forms
Cream
Label holder
KW ABSC, INC.
FDA application
part352
Label updated
11/24/2018

Active ingredients

Titanium Dioxide 8.79% Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 3.00%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

Keep out of reach of children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cyclomethicone, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides (CI 77492), Diisostearyl Malate, Sodium Chloride, Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Sorbitan Olivate, Mica (CI 77019), Silica, Vegetable Oil, Iron Oxides (CI 77491), Chlorphenesin, Dipropylene Glycol, Polyester-1, Iron Oxides (CI 77499), Dimethicone, Silica Dimethyl Silylate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Propylene Carbonate, 1,2-Hexanediol, Hydroxyacetophenone, Cananga Odorata Flower Oil, Adenosine, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Tocopherol

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Cream2.1 mg/30mL / .9 mg/30mL / 2.6376 mg/30mLtopical1

Manufacturers and labels

1 FDA label

  • KW ABSC, INC.Shown herepart352 · Label 11/24/2018 · NDC 69231-023Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

CLE CCC Warm Light: common questions

What is CLE CCC Warm Light used for?
Helps prevent sunburn
Is CLE CCC Warm Light a prescription drug?
No. CLE CCC Warm Light is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as CLE CCC Warm Light?
Yes. Other FDA-listed products with the same active ingredients include CLE CCC Cool Medium Deep, CLE CCC Golden Medium, CLE CCC Golden Medium Deep, CLE CCC Neutral Fair.
Who makes CLE CCC Warm Light?
KW ABSC, INC. lists CLE CCC Warm Light with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/24/2018 · Label text is shown as published by the manufacturer. Not medical advice