Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Cross-Brands Contract Filling
TOPICAL
OTC DRUG
OTC monograph final
SEA AND SKI SPF 30- AVOBENXONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE LOTION CROSS-BRANDS CONTRACT FILLING _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- SEA&SKI SPF 30 LOTION 3.4OZ SEA AND SKI SPF 30 avobenxone, octisalate, homosalate, octocrylene lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:73440-2015 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.85 g in 95 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 14.25 g in 95 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 95 g Cross-Brands Contract Filling OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.75 g in 95 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) 49.5 g in 95 g PRODUCT CHARACTERISTICS COLOR white SCORE SHAPE SIZE FLAVOR IMPRINT CODE CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:73440- 2015-1 95 g in 1 TUBE; Type 0: Not a Combination Product 01/04/2017 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part352 01/04/2017 LABELER - Cross-Brands Contract Filling (117871824) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Cross Brands Contract Filling 117871824 label(73440-2015) , manufacture(73440-2015) , pack(73440-2015) Revised: 2/2021 Lees het volledige document