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

Sol-Or Kids by

Drug Labeling and Warnings

Sol-Or Kids 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

• Continued use of sunscreen can reduce the risk of cancer and premature skin aging caused by the sun. ( seeDirections)

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 30 Continuous Spray

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0283
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: 13630-0283-4	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(13630-0283) , label(13630-0283) , analysis(13630-0283) , pack(13630-0283)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0283) , pack(13630-0283)