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Premium Moisturizing Sunscreen Broad Spectrum SPF 70

Premium Moisturizing Sunscreen Broad Spectrum SPF 70

Approved
Approval ID

36da7117-1c8e-7fcf-e063-6294a90aed00

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Sun Bum, LLC

DUNS: 028642574

Products 1

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

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69039-695
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (13)

.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TRISILOXANEInactive
Code: 9G1ZW13R0G
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 100 mg in 1 g
Code: 5A68WGF6WM
Classification: ACTIB
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
HOMOSALATEActive
Quantity: 100 mg in 1 g
Code: V06SV4M95S
Classification: ACTIB
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)Inactive
Code: T9296U138P
Classification: IACT
OCTISALATEActive
Quantity: 50 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PPG-5-CETETH-20Inactive
Code: 4AAN25P8P4
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW)Inactive
Code: 7LL6SY9YFV
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

Primary Packaging

OG SPF 70 Spray

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

OTC - PURPOSE SECTION

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

Purpose

Sunscreen

WARNINGS SECTION

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

Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

Do not use on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.

• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

​Keep Out Of Reach Of Children

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 1/1/2025

Directions

• shake well before use

• hold container 4 to 6 inches from the skin to apply

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• do not spray directly onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

• reapply: after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: ask a doctor

• 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 value 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-sleeved shirts, pants, hats and sunglasses

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

Directions

• shake well before use

• hold container 4 to 6 inches from the skin to apply

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• do not spray directly onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/1/2025

Other Information

protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

Inactive Ingredients

alcohol denat. (65%), polyester-8, acrylates/octylacrylamide copolymer, ascorbyl palmitate, caprylic/capric triglyceride, dimethicone, fragrance, PPG-5-ceteth-20, tocopheryl acetate, trisiloxane

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2025

Questions?

1-877-978-6286

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