SOL-OR BROAD SPECTRUM SPF- avobenzone, homosalate, octisalate, octocrylene spray

Sol-Or by

Drug Labeling and Warnings

Sol-Or by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 2.75%

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.

Do not use

on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure- do not puncture or incinerate.

Do not store at temoeratures above 120°F.

Stop use and ask doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable

Do not use near heat, flame or while smoking.

.

Directions

• Spray liberally and spread evenly by hand 15 minutes before sun exposure, hold container 4 to 6 inches from the skin to apply, do not spray directly into face. Spray on hands then apply to face, do not apply in windy conditions, use in a well-ventilated area.
• 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 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-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor

Inactive Ingredients

Aloe Barbadensis Extract, Cocos Nucifera (Coconut) Oil, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Isopropyl Alcohol, Mineral Oil (Paraffinum Liquidum), Polyester-8, SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

• Protect this product from excessive heat and direct sun.
• Avoid spraying on fabrics-could cause discoloration.

Question or comments?

Medellin: 266 9131 Colombia: 01 8000 9 76567 SOLOR sol-or.com

Mercadeo@quifarma.com

NO-AD Sunscreen Broad Spectrum SPF 50 Continuous Spray

INGREDIENTS AND APPEARANCE

SOL-OR  BROAD SPECTRUM SPF
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0284
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	126.75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.24 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.25 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
COCONUT OIL (UNII: Q9L0O73W7L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0284-4	149 g in 1 CAN; Type 0: Not a Combination Product	09/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/20/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0284) , label(13630-0284) , analysis(13630-0284) , pack(13630-0284)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0284) , pack(13630-0284)