SUNBEAT PROCARE FPS 50 KIDS- homosalate, octocrylene, octisalate, avobenzone, ensulizole lotion

SUNBEAT PROCARE FPS 50 KIDS by

Drug Labeling and Warnings

SUNBEAT PROCARE FPS 50 KIDS by is a Otc medication manufactured, distributed, or labeled by Tecnoglobal, PH7 S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNBEAT PROCARE FPS 50 KIDS 
homosalate, octocrylene, octisalate, avobenzone, ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75470-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 mg  in 60 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	14 mg  in 60 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 60 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 60 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 mg  in 60 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)	1 mg  in 60 mg
CETYL ALCOHOL (UNII: 936JST6JCN)	1 mg  in 60 mg
DECYLENE GLYCOL (UNII: S57M60MI88)	1 mg  in 60 mg
BEESWAX (UNII: 2ZA36H0S2V)	1 mg  in 60 mg
PHENOXYETHANOL (UNII: HIE492ZZ3T)	1 mg  in 60 mg
WATER (UNII: 059QF0KO0R)	13 mg  in 60 mg
CARBOMER (UNII: 0A5MM307FC)	1 mg  in 60 mg
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)	1 mg  in 60 mg
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)	1 mg  in 60 mg
SODIUM HYDROXIDE (UNII: 55X04QC32I)	1 mg  in 60 mg
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)	1 mg  in 60 mg
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	1 mg  in 60 mg
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)	1 mg  in 60 mg
PEG-100 (UNII: TVH7653921)	1 mg  in 60 mg
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)	1 mg  in 60 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75470-303-01	60 mg in 1 TUBE; Type 0: Not a Combination Product	11/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2025

Labeler - Tecnoglobal, PH7 S.A. DE C.V. (813006665)

Registrant - Tecnoglobal, PH7 S.A. DE C.V. (813006665)

Establishment
Name	Address	ID/FEI	Business Operations
Tecnoglobal, PH7 S.A. DE C.V.		813006665	manufacture(75470-303) , label(75470-303)