KIDS SUNSCREEN SPF 50- avobenzone 3% , homosalate 10%,octisalate 5% spray

Kids Sunscreen SPF 50 by

Drug Labeling and Warnings

Kids Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Rocky Mountain, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Avobenzone 3% ........................................................ Sunscreen Homosalate 10% ...................................................... Sunscreen Octisalate 5% ............................................................Sunscreen

PURPOSE

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:Do not use white smoking or near heat or flame.

Do not useon damaged or broken skin.
When using this product■ keep out of eyes. Rinse eyes with water
to remove.
Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.

Iswallowed, get medical help or contact a Polson Control Center right away.

Directions

 ■ apply liberally 15 minutes before sun exposure.
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 risk, regularly use a
sunscreen with broad spectrum SPF of 15 or higher and other sun
protection measures lncludlng: ■ limit time In the sun, especlally
from 10am to 2pm ■ wear long-sleeved shirts, pants, hats, and
sunglasses ■ children under 6 months: ask a doctor ■ do not spray
directly Into face. Spray on hands then apply to face ■ use In
well-ventilated area.

Other information

protect this product from excessive
heat and direct sun ■ may stain fabrics.

Inactive Ingredients

Butyloctyi Sallcylate, Ethyl Alcohol
Denatured, Polyester-8, Oryza Sativa (Rice Bran) Oil, VA/Butyl
Maleate/lsobomyl Acrylate Copolymer.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS SUNSCREEN SPF 50 
avobenzone 3% , homosalate 10%,octisalate 5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49757-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ORYZA SATIVA (RICE) SEED OIL (UNII: ACU8G2V809)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49757-011-12	907 g in 1 CONTAINER; Type 0: Not a Combination Product	08/21/2027
2	NDC: 49757-011-22	3629 g in 1 CONTAINER; Type 0: Not a Combination Product	08/21/2027

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M20	08/21/2025

Labeler - Rocky Mountain (032180460)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(49757-011)