SUN BASICS BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

Sun Basics by

Drug Labeling and Warnings

Sun Basics by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

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.

Stop use and ask a 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.

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 this risk, regularly use a sunscreen with 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Other information

protect this product from excessive heat and direct sun

Sun Basics SPF 30 Sport Sunscreen Lotion

INGREDIENTS AND APPEARANCE

SUN BASICS  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0512
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.19 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.65 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	48.65 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	72.98 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCOA BUTTER (UNII: 512OYT1CRR)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER 980 (UNII: 4Q93RCW27E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0512-3	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/06/2021	05/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	05/06/2021	05/31/2024

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0512) , manufacture(58443-0512) , label(58443-0512) , analysis(58443-0512)