SEA AND SKI SPF 30- avobenxone, octisalate, homosalate, octocrylene lotion

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Produktets egenskaber Produktets egenskaber (SPC)
19-02-2021

Aktiv bestanddel:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Tilgængelig fra:

Cross-Brands Contract Filling

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Autorisation status:

OTC monograph final

Produktets egenskaber

                                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
                                
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