CALLIEL GLOW PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN- sunscreen cream cream

CALLIEL GLOW PRIMER Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

CALLIEL GLOW PRIMER Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by CALLIEL PHARMA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI, MADDY GLOBAL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethylhexyl Methoxycinnamate 8.51%

Octocrylene 5%

Butyl Methoxydibenzoylmethane 4.6%

Zinc Oxide 3.5%

Titanium Dioxide 3%

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

DO NOT USE

Do not use on damaged or broken skin

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months: Ask a doctor

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging caused by the sun. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses

Warnings

For external use only

Purpose

Sunscreen

Inactive ingredients

Aqua, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-20, Niacinamide, Butyrospermum Parkii Butter, Caprylic/Capric Triglyceride, Dimethicone, Glycerin, Alpha-Arbutin, Xylitylglucoside, Phenoxyethanol, Arachidyl Alcohol, Anhydroxylitol, Behenyl Alcohol, Xylitol, Arachidyl Glucoside, Xanthan Gum, Aloe Barbadensis Leaf Extract, CI 77491, Hyaluronic Acid, Caprylyl Glycol, Triethoxycaprylylsilane.

PRINCIPAL DISPLAY PANEL

CALLIEL

GLOW PRIMER

Broad Spectrum SPF 50 Sunscreen

Helps Protect Skin from Sunburn
Enhances Natural Radiance

with Alpha Arbutin, Niacinamide
and Hyaluronic Acid

Dermatologist Tested

50 mL (1.69 fl oz)

INGREDIENTS AND APPEARANCE

CALLIEL GLOW PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN 
sunscreen cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87411-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 g
BUTYL METHOXYDIBENZOYLMETHANE (UNII: G63QQF2NOX) (BUTYL METHOXYDIBENZOYLMETHANE - UNII:G63QQF2NOX)	BUTYL METHOXYDIBENZOYLMETHANE	4.6 g  in 100 g
ETHYLHEXYL METHOXYCINNAMATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	ETHYLHEXYL METHOXYCINNAMATE	8.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.6 g  in 100 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.12 g  in 100 g
ANHYDROXYLITOL (UNII: 8XWR7NN42F)	0.32 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.82 g  in 100 g
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)	0.32 g  in 100 g
GLYCERYL STEARATE (UNII: 230OU9XXE4)	3.2 g  in 100 g
CETEARETH-20 (UNII: YRC528SWUY)	3.2 g  in 100 g
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)	1.63 g  in 100 g
CI 77491 (UNII: 1K09F3G675)	0.12 g  in 100 g
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)	5.6 g  in 100 g
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)	0.18 g  in 100 g
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)	0.12 g  in 100 g
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)	0.01 g  in 100 g
CETEARYL ALCOHOL (UNII: 2DMT128M1S)	5.2 g  in 100 g
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)	1.3 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O)	1.61 g  in 100 g
ALPHA-ARBUTIN (UNII: 72VUP07IT5)	1.52 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4)	3.2 g  in 100 g
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)	2.5 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E)	0.32 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.16 g  in 100 g
BEHENYL ALCOHOL (UNII: 9G1OE216XY)	0.32 g  in 100 g
AQUA (UNII: 059QF0KO0R)	41.51 g  in 100 g
HYALURONIC ACID (UNII: S270N0TRQY)	0.12 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87411-0005-1	50 g in 1 TUBE; Type 0: Not a Combination Product	02/07/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/07/2026

Labeler - CALLIEL PHARMA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (751146029)

Registrant - MADDY GLOBAL LLC (144837954)

Establishment
Name	Address	ID/FEI	Business Operations
CALLIEL PHARMA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		751146029	manufacture(87411-0005)