SUNPLUS SUNSCREEN LAGUNA- sunscreen lotion

Sunplus Sunscreen Laguna by

Drug Labeling and Warnings

Sunplus Sunscreen Laguna by is a Otc medication manufactured, distributed, or labeled by I Shay Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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.

WARNINGS

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

INACTIVE INGREDIENT

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)

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

OTHER SAFETY INFORMATION

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

INGREDIENTS AND APPEARANCE

SUNPLUS SUNSCREEN LAGUNA 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65112-263
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	51.4 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65112-263-01	136 g in 1 TUBE; Type 0: Not a Combination Product	01/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/17/2021

Labeler - I Shay Cosmetics Inc (151582384)