SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene spray

Sunscreen SPF 30 by

Drug Labeling and Warnings

Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

• Flammable: Keep away from fire or flame.
• after application, wait until product dries before approaching a source of heat or flame, or before smoking

Do not use

• on damaged or broken skin

When using this product

• keep out of eyes.  Rinse with water to remove.
• contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF.

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 right away.

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• apply to all skin exposed to the sun 
• hold container 4 to 6 inches from the skin to apply
• do not apply in windy conditions
• use in a well-ventilated area and avoid inhalation
• reapply: 
• after 80 minutes of swimming or sweating 
• immediately after towel drying
• at least every 2 hours
• 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 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• 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

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, triethanolamine, tocopherol, butyloctyl salicylate, fragrance

Disclaimer

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by S.C. Johnson, distributor of Sun Bum ® Premium Moisturizing Sunscreen Spray Broad Spectrum SPF 30.

Adverse reaction

Manufactured by: Vi-Jon, LLC

One Swan Drive

Smyrna, TN 37167

Principle display panel

Wild Tropics™

Sunscreen Spray

BROAD SPECTRUM SPF 30

Phthalate free

Hypoallergenic

Dermatologist tested

Water resistant (80 minutes)

Fresh Banana Scent

Compare to Sun Bum ® Premium Moisturizing Sunscreen Spray*

SPF 30

NET WT 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-109-14	156 g in 1 CAN; Type 0: Not a Combination Product	03/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2024

Labeler - Nice-Pak Products, LLC (119091520)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(11344-109)