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Broad Spectrum SPF 30 sunscreen

SPF 30 (Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 8.0%)

Approved
Approval ID

a01f0ab9-d686-4ee1-be39-fd4c061cb018

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Florida Squeezed

DUNS: 085400921

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Homosalate 7.5%, Octisalate 5.0%, Avobenzone 3.0%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83810-011
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Homosalate 7.5%, Octisalate 5.0%, Avobenzone 3.0%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (12)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ALOEInactive
Code: V5VD430YW9
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
ORANGE OILInactive
Code: AKN3KSD11B
Classification: IACT
FRAGRANCE 13576Inactive
Code: 5EM498GW35
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ORYZA SATIVA (RICE) BRANInactive
Code: R60QEP13IC
Classification: IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)Inactive
Code: T9296U138P
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
AVOBENZONEActive
Quantity: 3 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 15 g in 100 g
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 7.5 g in 100 g
Code: 4X49Y0596W
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/25/2025

Uses

· helps prevent sunburn

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/25/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/26/2025

Active Ingredients Purpose

Avobenzone 3.0%, Homosalate 7.5 %,
Octisalate 5.0%,,,,,,,,,,,,,,,,,,,,,,,,,,,.............Sunscreen

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/25/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 8/25/2025

Warnings

For external use only.

**Flammable:**Do not use near heat, flame or while smoking.
Do not useon damaged or broken skin.
When using this product· keep out of eyes . Rinse with water to
remove. · Do not puncture or incinerate. Contents under pressure. Do
not store at temperatures above 1200F.
Stop use and ask doctor ifrash occurs.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/25/2025

Directions

Shake well before usng · spray liberally and spread evenly by hand 15 minutes before sun exposure · reapply: · after 80
minutes of swimming or sweating · immediately after towel drying · at least every 2 hours · hold container 4 tob 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.
·**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 a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/25/2025

Other information ·

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

Alcohol, ALOE, BUTYLOCTYL SALICYLATE, ORANGE OIL, FRAGRANCE, MINERAL OIL, ORYZA SATIVA (RICE) BRAN, POLYESTER-8, tocopheryl acetate

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