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FDA Warning Letter Explorer
FDA warning letter · Drugs

Kalani AB dba Kalani Sunwear

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Accordingly, your “Kalani sunwear SUN MOUSSE SPF 50” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Passage 2

Therefore, as formulated and labeled, “Kalani sunwear SUN MOUSSE SPF 50” does not comply with the applicable conditions specified in M020 and has not otherwise been found GRASE.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.128