ROUND AROUND GRRENTEA CICA SUN ZINC OXIDE: Package Insert and Label Information

ROUND AROUND GRRENTEA CICA SUN ZINC OXIDE- zinc oxide lotion
CJ Olive Young Corporation

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

ZINC OXIDE 17.00%

INACTIVE INGREDIENTS

WATER, CYCLOHEXASILOXANE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, PROPYLHEPTYL CAPRYLATE, ISODODECANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DICAPRYLYL CARBONATE, CAPRYLYL METHICONE, METHYL METHACRYLATE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, POLYMETHYLSILSESQUIOXANE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, GLYCERYL CAPRYLATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, SODIUM HYALURONATE, LITSEA CUBEBA FRUIT OIL, TOCOPHEROL, MADECASSOSIDE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT, CENTELLA ASIATICA LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, MENTHA AQUATICA EXTRACT

PURPOSE

Sunscreen

WARNINGS

■ FOR EXTERNAL USE ONLY
■ If you experience any symptoms such as redness, swelling, or itchiness during usage or from exposure to direct sunlight after usage, suspend use and consult a physician.
■ Do not use on wounds or other areas of skin irritation.
■ Keep out of reach of children.
■ Keep away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

■ Keep out of reach of children.

Uses

■ Helps prevent sunburn
■ Higher SPF gives more sunburn protection

Directions

■ As the final step of your skin care regimen, apply to areas easy to be exposed to UV rays,including face and neck.
■ Apply every 2-3 hours for outdoor activity.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ROUND AROUND GRRENTEA CICA SUN ZINC OXIDE
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81540-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 17 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 6
BUTYLOCTYL SALICYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81540-060-02 1 TUBE in 1 CARTON contains a TUBE (81540-060-01)
1 NDC:81540-060-01 10 mL in 1 TUBE This package is contained within the CARTON (81540-060-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2022
Labeler — CJ Olive Young Corporation (695640147)
Registrant — CJ Olive Young Corporation (695640147)
Establishment
Name Address ID/FEI Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611 manufacture (81540-060)

Revised: 08/2022 CJ Olive Young Corporation

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