SUNPLUS SUNSCREEN YOSEMITE SPF 45- sunscreen lotion 
I Shay Cosmetics 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.

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Sunplus Face + Body Sunscreen Yosemite SPF 45

ZINC OXIDE 9.75%, OCTINOXATE 7.5%, OCTISALATE 5%

Helps prevent sunburn and photodamage - If used as directed with other sun protection measures (See Directions). decreases the risks of skin cancer and early aging caused by the sun.

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.

If swallowed, get medical help or contact poison control center

Keep out of reach of children

Purified Water, Capric/Caprylic, Glycerin, Cetearyl Alcohol, Ceteareth-20, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethilconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Acrylate Copolymer, Phenoxyethanol, Ethylhexylglycerin, Helianthus annuus (Sunflower) Seed Oil, Carthamus tinctorius (Safflower) Seed Oil, Vitis vinifera (Grape) Seed Oil, Allantoin, Hyaluronic acid, Oenothera Biennis (Evening Primrose) Borago officinalis (Starflower) Oil, Rubus idaeus (Red Raspberry) Seed Oil, Bisobolol (Chamomile)

Apply liberally to dry skin 15 minutes before sun exposure *Reapply to dry skin after 80 minutes of swimming or sweating *immediately after towel drying * at least every 2 hours * Children under 6 months ask a doctor

OTHER iNFORMATION Protect the product in this container from excessive heat and direct sun.

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures, including * Limit time in the sun, especially from 10a.m. – 2 p.m. * Wear long-sleeved shirts, pants, hats, and sunglasses

label

label

SUNPLUS SUNSCREEN YOSEMITE SPF 45 
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65112-264
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 51.4 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65112-264-01136 g in 1 TUBE; Type 0: Not a Combination Product01/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/17/2021
Labeler - I Shay Cosmetics Inc (151582384)

Revised: 1/2021
Document Id: b9bdc39e-8ea6-615c-e053-2a95a90afe1b
Set id: 92dd6756-c458-bbbe-e053-2a95a90a24f5
Version: 11
Effective Time: 20210125
 
I Shay Cosmetics Inc