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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SUNTEGRITY MINERAL SUNSTICK SPF30 22 GRAM
SUNTEGRITY SUNSTICK ART DRK OMBRE OTL
SUNTEGRITY MINERAL SUNSTICK DRUG LABEL
SUNSCREEN
zinc oxide sunscreen stick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 29 32-173
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
22 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
.BETA.-CITRO NELLO L, ( +/-) - (UNII: 56 5OK72VNF)
SUNFLO WER O IL (UNII: 3W1JG79 5YI)
WHITE WAX (UNII: 7G1J5DA9 7F)
SHEA BUTTER (UNII: K49 155WL9 Y)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
CO CO NUT O IL (UNII: Q9 L0 O73W7L)
GERANIO L (UNII: L8 3710 8 USY)
CITRUS SINENSIS FLO WER O IL (UNII: AJ56 JP5TFP)
TO CO PHERO L (UNII: R0 ZB2556 P8 )
CANDELILLA WAX (UNII: WL0 328 HX19 )
CARNAUBA WAX (UNII: R12CBM0 EIZ)
CASTO R O IL (UNII: D5340 Y2I9 G)
CO CO A BUTTER (UNII: 512OYT1CRR)
LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)
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 32-173-26
22 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
12/31/20 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
12/31/20 18
Private Label Select Ltd CO
LABELER -
Private Label Select Ltd CO (005415463)
REGISTRANT -
Private Label Select Ltd CO (005415463)
Revised: 7/2020