Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Advanced Protection Sunscreen spf 30
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Drug: Octisalate
- Recalling firm
- CBI Laboratories, Inc.
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0341-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Octisalate recalls
See all
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class I · High risk
Coppertone SPORT Sunscreen Spray 50
Chemical contamination; presence of benzene
Other recalls by CBI Laboratories, Inc.
All 2018 recalls
Class III · Low risk
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
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