SPL v26
SPL
SPL Set ID 435e6717-5fbf-5cb2-e063-6294a90a40d7
Route
CUTANEOUS
Published
Effective Date 2025-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Palmitoyl Tripeptide-8 (1 g)
Inactive Ingredients
Water Piper Methysticum Whole Glycerin Glyceryl Glucoside Asiaticoside Dipotassium Glycyrrhizate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-02

Description

ACTIVE INGREDIENT


Medication Information

Warnings and Precautions



CAUTION

For external use only. Avoid directcontact with eyes. Ifirritation occurs, stop useand consult a doctor if needed.Patch test recommended.Do not use if you are allergic to any of theingredients.Keep out of reach of children.

Indications and Usage



USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently mistevenly over the skin. Allow it to absorb naturallyor lightly pat for better penetration. Follow withyour regular skincare routine.

Dosage and Administration



USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently mistevenly over the skin. Allow it to absorb naturallyor lightly pat for better penetration. Follow withyour regular skincare routine.

Description

ACTIVE INGREDIENT

Section 50565-1



CAUTION

For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

Section 50566-9



CAUTION

For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

Section 50567-7



USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently mistevenly over the skin. Allow it to absorb naturallyor lightly pat for better penetration. Follow withyour regular skincare routine.

Section 50570-1



CAUTION

For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

Section 51727-6

Water(Aqua), Tremella fuciformis extract, glycerin, Dendrobium ofcinale stemextract, calcium gluconate, beta glucan

Section 51945-4



ODLUMIVIE

DERMA-BEAUTY

Soothing

Calming

HIAIWAT.QO

LHSI NMO NOA HLIM INIHS

ALny38-yW830

USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently misevenly over the skin. Allow it to absorb naturallor lightly pat for better penetration. Follow wit!your regular skincare routine.

INGREDIENTS

Water(Aqua),Glycerin, Piper MethysticumLeaf/Root/Stem Extract, Glyceryl GlucosideAsiaticoside, Dipotassium Glycyrrhizate,Beta-Glucan, Palmitoyl, Tripeptide-8

KEY BENEFITS

Powered py rare actives including PiperMethysticum extract,celebrated for its potentcalming and anti-stress properties to ease visiblirritation:Asiaticoside,a purifed CentellaAsiatica compound known to accelerate skinrepair, support collagen synthesis, and improvoverall skin texture: and Palmitoyl Tripeptide-8an advanced peptide clinically proven to reducinfammation and sensitivity, this formula workin synergy to rapidly relieve discomfort, visiblydiminish redness, fortify the skin's naturalbarrier, and enhance resilience-leaving thecomplexion calm,balanced, and radiantly

healthy-looking.

CAUTIONFor external use only, Avoid directcontact with eyes. Ifirritation occurs, stop useand consult a doctor ifneeded.Patch test recommended.Do not use ifyou are allergic to any of the

Restoring

Peptide CalmMist Spray

For Sensitive & Rosacea-Prone Skinsuitable for all skin types

ingredients.

Keep out ofreach ofchildren.

Made in South KoreaDistributed by ODTUMIVIEMiami, Florida,USA,33157

wwwodlumivie.com

Section 55105-1

KEY BENEFITSPowered by rare actives including PiperMethysticum extract, celebrated for its potentcalming and anti-stress properties to ease visibleirritation; Asiaticoside, a purifed CentellaAsiatica compound known to accelerate skinrepair, support collagen synthesis, and improveoverall skin texture; and Palmitoyl Tripeptide-8,an advanced peptide clinically proven to reduceinflammation and sensitivity, this formula worksin synergy to rapidly relieve discomfort, visiblydiminish redness, fortify the skin's naturalbarrier, and enhance resilience-leaving thecomplexion calm, balanced, and radiantlyhealthy-looking

Section 55106-9

ACTIVE INGREDIENT


Structured Label Content

Indications and Usage (34067-9)



USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently mistevenly over the skin. Allow it to absorb naturallyor lightly pat for better penetration. Follow withyour regular skincare routine.

Dosage and Administration (34068-7)



USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently mistevenly over the skin. Allow it to absorb naturallyor lightly pat for better penetration. Follow withyour regular skincare routine.

Warnings and Precautions (34071-1)



CAUTION

For external use only. Avoid directcontact with eyes. Ifirritation occurs, stop useand consult a doctor if needed.Patch test recommended.Do not use if you are allergic to any of theingredients.Keep out of reach of children.

Section 50565-1 (50565-1)



CAUTION

For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

Section 50566-9 (50566-9)



CAUTION

For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

Section 50567-7 (50567-7)



USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently mistevenly over the skin. Allow it to absorb naturallyor lightly pat for better penetration. Follow withyour regular skincare routine.

Section 50570-1 (50570-1)



CAUTION

For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

Section 51727-6 (51727-6)

Water(Aqua), Tremella fuciformis extract, glycerin, Dendrobium ofcinale stemextract, calcium gluconate, beta glucan

Section 51945-4 (51945-4)



ODLUMIVIE

DERMA-BEAUTY

Soothing

Calming

HIAIWAT.QO

LHSI NMO NOA HLIM INIHS

ALny38-yW830

USAGE

After cleansing, hold the bottle 15-20 cm awayfrom your face, close your eyes, and gently misevenly over the skin. Allow it to absorb naturallor lightly pat for better penetration. Follow wit!your regular skincare routine.

INGREDIENTS

Water(Aqua),Glycerin, Piper MethysticumLeaf/Root/Stem Extract, Glyceryl GlucosideAsiaticoside, Dipotassium Glycyrrhizate,Beta-Glucan, Palmitoyl, Tripeptide-8

KEY BENEFITS

Powered py rare actives including PiperMethysticum extract,celebrated for its potentcalming and anti-stress properties to ease visiblirritation:Asiaticoside,a purifed CentellaAsiatica compound known to accelerate skinrepair, support collagen synthesis, and improvoverall skin texture: and Palmitoyl Tripeptide-8an advanced peptide clinically proven to reducinfammation and sensitivity, this formula workin synergy to rapidly relieve discomfort, visiblydiminish redness, fortify the skin's naturalbarrier, and enhance resilience-leaving thecomplexion calm,balanced, and radiantly

healthy-looking.

CAUTIONFor external use only, Avoid directcontact with eyes. Ifirritation occurs, stop useand consult a doctor ifneeded.Patch test recommended.Do not use ifyou are allergic to any of the

Restoring

Peptide CalmMist Spray

For Sensitive & Rosacea-Prone Skinsuitable for all skin types

ingredients.

Keep out ofreach ofchildren.

Made in South KoreaDistributed by ODTUMIVIEMiami, Florida,USA,33157

wwwodlumivie.com

Section 55105-1 (55105-1)

KEY BENEFITSPowered by rare actives including PiperMethysticum extract, celebrated for its potentcalming and anti-stress properties to ease visibleirritation; Asiaticoside, a purifed CentellaAsiatica compound known to accelerate skinrepair, support collagen synthesis, and improveoverall skin texture; and Palmitoyl Tripeptide-8,an advanced peptide clinically proven to reduceinflammation and sensitivity, this formula worksin synergy to rapidly relieve discomfort, visiblydiminish redness, fortify the skin's naturalbarrier, and enhance resilience-leaving thecomplexion calm, balanced, and radiantlyhealthy-looking

Section 55106-9 (55106-9)

ACTIVE INGREDIENT


Advanced Ingredient Data


Raw Label Data

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