Sunscreen SPF 70 by Sun Bum / Product Quest Mfg Sunscreen SPF 70

Sunscreen SPF 70 by

Drug Labeling and Warnings

Sunscreen SPF 70 by is a Otc medication manufactured, distributed, or labeled by Sun Bum, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSCREEN SPF 70  SUN BUM- avobenzone 3.0% homosalate 10.0% octinoxate 5.0% octisalate 5.0% octocrylene 10.0% lotion 
Sun Bum

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunscreen SPF 70

Active ingredients                                                                                                                         Purpose

Avobenzone 3.0%, Homosalate 10.0%, Octinoxate 5.0%, Octisalate 5.0%, Octocrylene 10.0%     Sunscreen

Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the rick of skin cancer and early skin aging caused by the sun

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 product is swallowed, get medical help or contact a Poison Control Center right away

Directions
apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
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 long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive ingredients

Water
Beeswax
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
Dimethyl Capramide
Sodium Polyacrylate
Ethylhexylglycerin
Trimethylsiloxysilicate
Xanthan Gum
BHT
Dipotassium Glycyrrhizate
Polyaminopropyl Biguanide
Tocopheryl Acetate
Disodium EDTA
Methylisothiazolinone

Package Labeling

Front

Back

SUNSCREEN SPF 70   SUN BUM
avobenzone 3.0% homosalate 10.0% octinoxate 5.0% octisalate 5.0% octocrylene 10.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69039-565
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69039-565-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/201708/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/15/201708/31/2018
Labeler - Sun Bum (028642574)

Revised: 2/2020
 
Sun Bum