PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene spray

Premium Moisturizing Sunscreen Broad Spectrum SPF 70 by

Drug Labeling and Warnings

Premium Moisturizing Sunscreen Broad Spectrum SPF 70 by is a Otc medication manufactured, distributed, or labeled by Sun Bum, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

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

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.

Warnings

​Keep Out Of Reach Of Children

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

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 Information

protect this product from excessive heat and direct sun

Inactive Ingredients

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

Questions?

1-877-978-6286

Primary Packaging

INGREDIENTS AND APPEARANCE

PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 70 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-695
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRISILOXANE (UNII: 9G1ZW13R0G)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIMETHICONE (UNII: 92RU3N3Y1O)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-695-00	170 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2025

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

Labeler - Sun Bum, LLC (028642574)