FDA
.report
PMA
PMN
De Novo
MAUDE
GUDID
NDC
DailyMed
Drug Applications
CIELE BLUSH AND PROTECT JUNE- zinc oxide lotion
Drug Labeling and Warnings
Drug Details [
pdf
]
Ciele Blush and Protect June
Ciele Blush and Protect June
Ciele Blush and Protect June
Ciele Blush and Protect June
Ciele Blush and Protect June
Ciele Blush and Protect June
Ciele Blush and Protect June
Ciele Blush and Protect June
INGREDIENTS AND APPEARANCE
CIELE BLUSH AND PROTECT JUNE
zinc oxide lotion
Product Information
Product Type
HUMAN OTC DRUG
Item Code (Source)
NDC:
83103-1941
Route of Administration
TOPICAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
ZINC OXIDE
(UNII:
SOI2LOH54Z
) (ZINC OXIDE - UNII:
SOI2LOH54Z
)
ZINC OXIDE
73.6 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
TIN OXIDE
(UNII:
KM7N50LOS6
)
C26-28 ALKYL DIMETHICONE (2500 MW)
(UNII:
WWM99KDT6S
)
LAURYL PEG-8 DIMETHICONE (300 CPS)
(UNII:
ELL2U7K8T8
)
HYDROGENATED SOYBEAN LECITHIN
(UNII:
H1109Z9J4N
)
TITANIUM DIOXIDE
(UNII:
15FIX9V2JP
)
FERRIC OXIDE RED
(UNII:
1K09F3G675
)
LECITHIN, SOYBEAN
(UNII:
1DI56QDM62
)
PHENYLPROPANOL
(UNII:
0F897O3O4M
)
ISOHEXADECANE
(UNII:
918X1OUF1E
)
DISTEARDIMONIUM HECTORITE
(UNII:
X687XDK09L
)
TRIDECYL SALICYLATE
(UNII:
AZQ08K38Z1
)
ALLANTOIN
(UNII:
344S277G0Z
)
SODIUM HYDROXIDE
(UNII:
55X04QC32I
)
WATER
(UNII:
059QF0KO0R
)
TETRASODIUM GLUTAMATE DIACETATE
(UNII:
5EHL50I4MY
)
SODIUM CHLORIDE
(UNII:
451W47IQ8X
)
.ALPHA.-BISABOLOL, (+)-
(UNII:
105S6I733Z
)
ALKYL (C12-15) BENZOATE
(UNII:
A9EJ3J61HQ
)
SILICON DIOXIDE
(UNII:
ETJ7Z6XBU4
)
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
(UNII:
Z570VEV8XK
)
GLYCERIN
(UNII:
PDC6A3C0OX
)
METHYLPROPANEDIOL
(UNII:
N8F53B3R4R
)
DIMETHICONE
(UNII:
92RU3N3Y1O
)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE
(UNII:
687U3PEB2Y
)
CAPRYLYL GLYCOL
(UNII:
00YIU5438U
)
FERRIC OXIDE YELLOW
(UNII:
EX438O2MRT
)
PROPYLENE CARBONATE
(UNII:
8D08K3S51E
)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE
(UNII:
YK3DC63Y5M
)
FERROSOFERRIC OXIDE
(UNII:
XM0M87F357
)
CAPRYLIC/CAPRIC TRIGLYCERIDE
(UNII:
C9H2L21V7U
)
CAPRYLYL METHICONE
(UNII:
Q95M2P1KJL
)
BLUE 1 LAKE
(UNII:
J9EQA3S2JM
)
Product Characteristics
Color
pink
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:
83103-1941-2
1 in 1 CARTON
06/23/2023
1
NDC:
83103-1941-1
5.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2
NDC:
83103-1941-3
2.7 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
06/26/2025
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC Monograph Drug
M020
06/23/2023
Labeler -
Ciele LLC (105041170)
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.