SUNSCREEN- zinc oxide sunscreen stick

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

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

SUNSCREEN- ZINC OXIDE SUNSCREEN STICK
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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THINK OPERATIONS, THINK BABY SPF 30 STICK CANADIAN
OTC - KEEP OUT OF REACH OF CHILDREN
OTC - ACTIVE INGREDIENTS
DOS AGE
INACTIVE INGREDIENTS
INDICATIONS AND USAGE
PURPOSE SECTION
WARNINGS
FRONT LABEL
BACK LABEL
UNIT CARTON PART 1
UNIT CARTON PART 2
SUNSCREEN
zinc oxide sunscreen stick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 29 32-212
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
20 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
Private Label Select Ltd CO
CO CO NUT O IL (UNII: Q9 L0 O73W7L)
SUNFLO WER O IL (UNII: 3W1JG79 5YI)
.BETA.-TO CO PHERO L (UNII: 9 U6 A49 0 50 1)
CANDELILLA WAX (UNII: WL0 328 HX19 )
SHEA BUTTER (UNII: K49 155WL9 Y)
CASTO R O IL (UNII: D5340 Y2I9 G)
WHITE WAX (UNII: 7G1J5DA9 7F)
CARNAUBA WAX (UNII: R12CBM0 EIZ)
CO CO A BUTTER (UNII: 512OYT1CRR)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
S HAP E
S IZ E
FLAVOR
FRUIT (Papaya Lychee)
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE MARKETING END DATE
1
NDC:6 29 32-212-
19
1 in 1 CARTON
0 5/0 1/20 19
1
18 .4 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct
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 19
LABELER -
Private Label Select Ltd CO (005415463)
Revised: 12/2019