Class II · Moderate risk Ongoing
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC…
Reason CGMP Deviations
Is Octinoxate recalled?
24 FDA recalls mention Octinoxate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Octinoxate.
Class II · Moderate risk Ongoing
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA…
Reason CGMP Deviations
Class II · Moderate risk Terminated
(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl…
Reason GMP Deviations
Class II · Moderate risk Terminated
Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%…
Reason Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk Terminated
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz…
Reason Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Class II · Moderate risk Terminated
EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips…
Reason Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen…
Class II · Moderate risk Terminated
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b)…
Reason Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class II · Moderate risk Terminated
LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1…
Reason Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found…
Class III · Low risk Terminated
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For…
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk Terminated
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class II · Moderate risk Terminated
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Reason GMP Deviations
Class II · Moderate risk Terminated
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by…
Reason GMP Deviations
Class II · Moderate risk Terminated
Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz)…
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk Terminated
Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada…
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk Terminated
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc…
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0%…
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide…
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%)…
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Ongoing
Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%…
Reason Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Class II · Moderate risk Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad…
Reason cGMP Deviations; product does not comply with cGMP requirements
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.