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

Superscreen Hydrating Daily Cream SPF 40 by

Drug Labeling and Warnings

Superscreen Hydrating Daily Cream SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

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

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

Superscreen Hydrating Daily Cream SPF 40 / 50 mL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-620
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-620-02	1 in 1 BOX	06/26/2023
1	NDC: 75936-620-01	50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/26/2023

Labeler - Supergoop, LLC (117061743)