SUPERSCREEN DAILY MOISTURIZER BROAD SPECTRUM SPF 40- avobenzone,homosalate, octisalate lotion

SuperScreen Daily Moisturizer Broad Spectrum SPF 40 by

Drug Labeling and Warnings

SuperScreen Daily Moisturizer Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Cosmetic Essence, LLC dba Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 2.5% Sunscreen

Homosalate 8% Sunscreen

Octisalate 5% Sunscreen

PURPOSE

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 bu 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.

INDICATIONS & USAGE

Stop use and ask a doctor and ask a doctor if rash occurs.

WARNINGS

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.

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 Measure​ 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 value of 15 or higher and other sun protection measures including:
• ​Limit time in the sun, especially from 10 a.m. - 2p.m.
• Wear Long-sleeved shirts, pants hats and sunglasses
• Children under 6 months ask a doctor

INACTIVE INGREDIENT

Inactive ingredients Water, Cartamus Tinctorius (safflower) Olesomes, Glycerin, C12-15 Alkyl Benzoate, Polyester-7, Ammonium Acryloyldimethyldimethyltaurate/VP Copolymer, Neopentyl Glycol Diheptanoate, Carthamus Tinctorius (Safflower) Seedcake extract, Aphanizomenon Flos-Aquae Extract, Inulin Lauryl Carbamate, Xanthan Gum, Biosaccharide Gum-4, Cerium Oxide, Platinum Powder, 1,2-hexanediol, Ehtylhexylglycerin, Phenethyl Alcohol, Chlorphenesin

PRINCIPAL DISPLAY PANEL

Sunscreen Daily Moisturizer SPF 40 Broad Spectrum Sunscreen

1.7 fl oz / 50ml

INGREDIENTS AND APPEARANCE

SUPERSCREEN DAILY MOISTURIZER BROAD SPECTRUM SPF 40 
avobenzone,homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYESTER-7 (UNII: 0841698D2F)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CARTHAMUS TINCTORIUS SEEDCAKE (UNII: DHQ13F4N2W)
CERIC OXIDE (UNII: 619G5K328Y)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
PLATINUM (UNII: 49DFR088MY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-506-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018
2	NDC: 75936-506-02	15 mL in 1 JAR; Type 0: Not a Combination Product	12/01/2018
3	NDC: 75936-506-03	10 mL in 1 JAR; Type 0: Not a Combination Product	12/01/2018
4	NDC: 75936-506-04	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2018

Labeler - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		825646862	manufacture(75936-506)