SUPERSCREEN HYDRATING DAILY CREAM SPF 40- avobenzone, homosalate, octisalate, octocrylene cream 
Supergoop, LLC

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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Superscreen Hydrating Daily Cream SPF 40

Active Ingredients: Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 1.5%

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

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

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

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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

Children under 6 months: Ask a doctor

Superscreen Hydrating Daily Cream SPF 40 / 50 mL

Carton

SUPERSCREEN HYDRATING DAILY CREAM SPF 40 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ECTOINE (UNII: 7GXZ3858RY)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL TRIOLEATE (UNII: O05EC62663)  
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)  
WATER (UNII: 059QF0KO0R)  
POLYESTER-7 (UNII: 0841698D2F)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
GLYCERYL DIOLEATE (UNII: Z3MP1W91CW)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
CERAMIDE NP (UNII: 4370DF050B)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-620-021 in 1 BOX06/26/2023
1NDC:75936-620-0150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/26/2023
Labeler - Supergoop, LLC (117061743)

Revised: 6/2023
Document Id: ff0e4e97-8f02-bd36-e053-6394a90a47ae
Set id: ff0e4e97-8f01-bd36-e053-6394a90a47ae
Version: 1
Effective Time: 20230626
 
Supergoop, LLC