REJUVE SUNSCREEN 100- inc oxide,octinoxate,octisalate,homosalate,titanium dioxide cream 
HUMEX,INC.

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 Ingredient Purpose

Active Ingredient

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

▪ Appy liberally 15 minutes before sun exposure
▪ Reapply at least every 2 hours
▪ Use a water-resistant sunscreen if swimming or sweating
▪ Children under 6 months of age: ask a doctor

Other Information

▪ protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Cyclomethicone,Glycerin,Propanediol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite,Magnesium Sulfate,Dimethicone,Glycol Dimethacrylate,Methyl Methacrylate Crosspolymer,Vinyl Dimethicone/Methicone,Silsesquioxane Crosspolymer,Triethoxycaprylylsilane,Fragrance,
Dimethicone/Peg-10/15 Crosspolymer,
Dimethicone/Vinyl Dimethicone,Crosspolymer,
Glyceryl Caprylate,Ethylhexylglycerin,Dipropylene Glycol,Ceramide Np,Sucrose Stearate,Sodium Citrate,Tocopherol,Cholesterol,Stearic Acid,Cholesteryl Macadamiate,Palmitic Acid,Butylene Glycol,Saccharide Isomerate,
Dipeptide Diaminobutyroyl Benzylamide,
Diacetate,Palmitoyl Tripeptide-5,Oligopeptide-10

display panel

REJUVE SUNSCREEN 100 
inc oxide,octinoxate,octisalate,homosalate,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76344-8005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 0.12 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL  in 100 mL
SACCHARIDE ISOMERATE (UNII: W8K377W98I) 0.01 mL  in 100 mL
OLIGOPEPTIDE-10 (UNII: Q46328TRNK) 0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T) 3 mL  in 100 mL
SUCROSE STEARATE (UNII: 274KW0O50M) 0.01 mL  in 100 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.01 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8) 0.01 mL  in 100 mL
STEARIC ACID (UNII: 4ELV7Z65AP) 0.01 mL  in 100 mL
PALMITIC ACID (UNII: 2V16EO95H1) 0.01 mL  in 100 mL
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 0.1 mL  in 100 mL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) 2.49 mL  in 100 mL
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.8 mL  in 100 mL
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 0.8 mL  in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O) 0.52 mL  in 100 mL
GLYCOL DIMETHACRYLATE (UNII: 7BK5G69305) 0.5 mL  in 100 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.5 mL  in 100 mL
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) 0.5 mL  in 100 mL
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.46 mL  in 100 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.04 mL  in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.01 mL  in 100 mL
CERAMIDE NP (UNII: 4370DF050B) 0.01 mL  in 100 mL
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) 0.01 mL  in 100 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) 0.01 mL  in 100 mL
CHOLESTERYL MACADAMIATE (UNII: DFP79OD7KP) 0.01 mL  in 100 mL
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R) 0.01 mL  in 100 mL
CYCLOMETHICONE (UNII: NMQ347994Z) 19.08 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76344-8005-21 in 1 BOX12/01/2020
1NDC:76344-8005-150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/2020
Labeler - HUMEX,INC. (017945311)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea689512611manufacture(76344-8005)

Revised: 1/2023
Document Id: f1ec9ba8-a023-63c2-e053-2a95a90a72c6
Set id: b8cd9668-2b42-3336-e053-2a95a90a92dd
Version: 2
Effective Time: 20230110
 
HUMEX,INC.