OTC Medication Information: PAPA RECIPE BOMBEE MOIST SUN ESSENCE

PAPA RECIPE BOMBEE MOIST SUN ESSENCE- octinoxate, homosalate, octisalate and titanium dioxide cream
Costory Co., Ltd

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.

ACTIVE INGREDIENTS

Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

INACTIVE INGREDIENTS

Water, Alcohol, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, 1,2-Hexanediol, Glycerin, Isononyl Isononanoate, Ethylhexyl Triazone, Polyglyceryl-3 Methylglucose Distearate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cyclopentasiloxane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Xanthan Gum, Tocopheryl Acetate, Sorbitan Isostearate, Ethylhexylglycerin, Allantoin, Limonene, Polysorbate 80, Sorbitan Oleate, Butylene Glycol, Citrus Limon (Lemon) Peel Oil, Sodium Hyaluronate, Rosa Damascena Flower Extract, Nelumbo Nucifera Flower Extract, Carthamus Tinctorius (Safflower) Flower Extract, Camellia Japonica Flower Extract, Citral, Honey Extract, Propolis Extract, Royal Jelly Extract, Sophora Japonica Fruit Extract, Ethyl Hexanediol, Lavandula Angustifolia (Lavender) Flower Extract, Viola Tricolor Extract, Centaurea Cyanus Flower Extract, Pancratium Maritimum Extract, Caprylyl Glycol

PURPOSE

Sunscreen

WARNINGS

For external use only. Discontinue use if signs of irritation or rashes appear. Keep out of direct sunlight.

Directions

■ For face, apply gently over your entire skin before sun exposure after your ritual daily moisturization.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PAPA RECIPE BOMBEE MOIST SUN ESSENCE
octinoxate, homosalate, octisalate, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73020-080
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (OCTINOXATE) Octinoxate 1.05 g in 15 mL
Homosalate (HOMOSALATE) Homosalate 0.45 g in 15 mL
Octisalate (OCTISALATE) Octisalate 0.45 g in 15 mL
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 0.22 g in 15 mL
Inactive Ingredients
Ingredient Name Strength
Water
Alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73020-080-01 15 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2020
Labeler — Costory Co., Ltd (694893916)
Registrant — Costory Co., Ltd (694893916)
Establishment
Name Address ID/FEI Operations
EYESOME. Co.,Ltd. 557795360 manufacture (73020-080)

Revised: 01/2021 Costory Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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