HAND SCREEN BROAD SPECTRUM SUNSCREEN SPF 40- avobenzone, octisalate, octocrylene lotion

Hand Screen Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

Hand Screen Broad Spectrum Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Cosway Company, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% 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 by the sun.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If swallowed, get medical help or contact a poison Control Center right away

INDICATIONS & USAGE

Stop use 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
• Use a water-resistant sunscreen if swimming or sweating
• Reapply 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 value of 15 or higher and other sun
• protection measures including: limit your time in the sun, especially from 10
• a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Propanediol, Glyceryl Stearate Citrate, Cocoglycerides, Isododecane, Cetyl Esters, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Arginine, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Polymethylsilsequioxane, Raphanus Sativus (Radish) Seed Oil, Diethylhexyl syringylidenemalonate, Helianthuus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Argania Spinosa Kernel Oil, Caprylic/Capric Triglyceride, Citrus Nobilis (Madarin Orange) Peel Oil, Plantago Lanceolata Leaf Extract, Glycine Soja (Soybean) Oil, Tocopherol, Cymbopogon Schoenanthus Oil, Hippophae Rhamnoides Fruit Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia Leaf Oil, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Grosso Herb Oil

PRINCIPAL DISPLAY PANEL

Supergoop!

Handscreen SPF 40

Broad Spectrum Sunscreen SPF 40

6.76 fl. oz. 200 ml.

INGREDIENTS AND APPEARANCE

HAND SCREEN BROAD SPECTRUM SUNSCREEN SPF 40 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
CETYL PHOSPHATE (UNII: VT07D6X67O)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL ESTERS WAX (UNII: D072FFP9GU)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISODODECANE (UNII: A8289P68Y2)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
CARDAMOM OIL (UNII: JM0KJ091HZ)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ARGAN OIL (UNII: 4V59G5UW9X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CLOVE LEAF OIL (UNII: VCA5491KVF)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
MANDARIN OIL (UNII: NJO720F72R)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
LAURYL LACTATE (UNII: G5SU0BFK7O)
ARGININE (UNII: 94ZLA3W45F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PROPANEDIOL (UNII: 5965N8W85T)
CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-151-01	4 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2019
2	NDC: 75936-151-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2019
3	NDC: 75936-151-03	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2019

Labeler - Taylor James, Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-151)