PREMIUM MOISTURIZING SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene spray

Premium Moisturizing Sunscreen SPF 30 by

Drug Labeling and Warnings

Premium Moisturizing Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%,
Octocrylene 3.75%

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.

Directions

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 into face. Spray on hands then apply to face.  do not apply in windy conditions use in well-ventilated area.  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

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

alcohol denat. (67%), acrylates/ octylacrylamide copolymer, C12-15 alkyl benzoate, dicaprylyl carbonate, PPG-5-ceteth-20, fragrance, tocopherol

Questions?

1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

PREMIUM MOISTURIZING SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-639
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	37.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-639-01	142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/02/2021

Labeler - Sun Bum LLC (028642574)