SEA AND SKI SPF 70- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
19-02-2021
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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)
Available from:
Cross-Brands Contract Filling
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Summary of Product characteristics
SEA AND SKI SPF 70- AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE,
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._
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SEA&SKI SPF 70 3.4OZ
SEA AND SKI SPF 70
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73440-2017
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
7.13 g in 95 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
OCTOCRYLENE
7.6 g in 95 g
Cross-Brands Contract Filling
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
OCTISALATE
4.75 g in 95 g
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
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
43.42 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-
2017-1
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 manufacture(73440-2017) , label(73440-2017) ,
pack(73440-2017)
Revised: 2/2021
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