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Ombra Sensitive With Zinc Sunscreen Lotion SPF50+, Ross Laboratories Aust Pty Ltd, CON-1047
Product name
Ombra Sensitive With Zinc Sunscreen Lotion SPF50+
Sponsor name
Ross Laboratories Aust Pty Ltd
ARTG details
- 387125
Consent start
Consent no.
CON-1047
Duration
The consent is effective from 9 December 2022 until 28 February 2023.
Standard
Ph. Eur. monograph 2584 of European Pharmacopoeia
Non-compliance with standard
The product does not comply because it does not meet the requirements for ID
test B – Hydroxyl Value and the Acid Value test, as the results are higher than
the limit.
Conditions imposed
The accelerated and real time stability testing will continue on the impacted
batches and any out of specification results observed during this stability
testing will be reported to the Therapeutics Goods Administration.
Import, Supply, &/or Export
supply
Therapeutic product type
Listed complementary medicines