Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

GMP Deviations

Recall #: D-0812-2018
Affected scope: 2,156 tubes
Initiated: May 4, 2018

Compiled from official public sources by the publisher. · Updated September 2026

Milbar Laboratories, Inc. recalled Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2… - a moderate-severity action.

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2… was recalled by Milbar Laboratories, Inc. in May 23, 2018. Reason: GMP Deviations. Check the official notice for the remedy. Verify recall #D-0812-2018 with the FDA Drug before acting.

The recall

Milbar Laboratories, Inc. issued this moderate-severity FDA Drug recall-GMP Deviations.

Moderate
severity level: Class II
classification: May 23, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0812-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

Reason for recall

GMP Deviations

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-0812-2018
Date reported	May 23, 2018
Date initiated	May 4, 2018
Recalling firm	Milbar Laboratories, Inc.
Firm location	East Haven, CT
Affected scope	2,156 tubes
Distribution	Within the United States and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0812-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128. Recalled by Milbar Laboratories, Inc.. Units affected: 2,156 tubes.

Why was this product recalled? ▼

GMP Deviations

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 23, 2018. Severity: Moderate. Recall number: D-0812-2018.

Where was the recalled product distributed? ▼

Distribution: Within the United States and Puerto Rico.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Kohler Recalls Automatic Transfer Switche… 2018-05-23 KIA 2015-2018: STRUCTURE:BODY:DOOR 2018-05-23 Sulfamethoxazole and Trimethoprim Tablets… 2018-05-23 Clindamycin 150 mg capsules, USP, 30-coun… 2018-05-23

Similar Cosmetics & Personal Care · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Calendula Cream, calendula officinalis 1X… 2018-05-23 Minivelle (estradiol transdermal system) … 2018-05-16 Minivelle (estradiol transdermal system) … 2018-05-16 Women’s Scarves Recalled by Wrapables Due… 2018-05-09

Compare this recall with Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 7… → · All Cosmetics & Personal Care recalls

This recall: FDA Drug, reported May 23, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026