SUN BUM SPF 70 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

Sun Bum SPF 70 Premium Moisturizing Sunscreen by

Drug Labeling and Warnings

Sun Bum SPF 70 Premium Moisturizing Sunscreen 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 15%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

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

Directions

• shake well before use
• apply liberally 15 minutes before sun exposure
• 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

water, cetyl palmitate, hydrated silica, acrylates/C12-22 alkyl methacrylate copolymer, caprylyl methicone, styrene/acrylates copolymer, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, polyester-8, trideceth-6, dimethicone, ethylhexyl stearate, fragrance, phenoxyethanol, dimethyl capramide, sodium polyacrylate, trimethylsiloxysilicate, xanthan gum, BHT, dipotassium glycyrrhizate, tocopheryl acetate, ethylhexyl glycerin, tetrasodium glutamate diacetate

Questions?

1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM SPF 70 PREMIUM MOISTURIZING SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-612
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-612-01	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2020

Labeler - Sun Bum LLC (028642574)