SUNSCREEN- zinc oxide sunscreen ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Private Label Select Ltd CO

INN (International Name):

ZINC OXIDE

Composition:

ZINC OXIDE 20 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

SUNSCREEN- ZINC OXIDE SUNSCREEN OINTMENT
PRIVATE LABEL SELECT LTD CO
_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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SUNSCREEN
zinc oxide sunscreen ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 29 32-16 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
Private Label Select Ltd CO
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
20 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CASTO R O IL (UNII: D5340 Y2I9 G)
YELLO W WAX (UNII: 2ZA36 H0 S2V)
O LIVE O IL (UNII: 6 UYK2W1W1E)
JO JO BA O IL (UNII: 724GKU717M)
SUNFLO WER O IL (UNII: 3W1JG79 5YI)
TO CO PHERO L (UNII: R0 ZB2556 P8 )
SHEA BUTTER (UNII: K49 155WL9 Y)
CO CO NUT O IL (UNII: Q9 L0 O73W7L)
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 29 32-16 1-22
8 5 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 18
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt352
0 5/0 1/20 18
LABELER -
Private Label Select Ltd CO (005415463)
REGISTRANT -
Private Label Select Ltd CO (005415463)
Revised: 3/2018