LIP SCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octisalate, octocrylene liquid

Lip Screen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Lip Screen Broad Spectrum 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

Avobenzone 3% Sunscreen

Homosalate 5% 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 product is 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

Hydrogenated Polyisobutene, Diisostearyl Malate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Polyurethane-79, Polyester-7, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Isopropyl Palmitate , Sesamum Inidicum (Sesame) Seed Oil, Neopentyl Glycol Diheptanoate, Diethylhexyl Syringlidenemalonate, Caprylyl Glycol, Glycine Soja (Soybean) Oil, Tocopherol, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Helianthus Annuus (Sunflower) Seed Oil, Ethyl Acetate, Stevioside, Gamma-Undecalactone, Vanillin, Vitis Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract, Citric Acid

PRINCIPAL DISPLAY PANEL

Lip Screen

SPF 40

Broad Spectrum SPF 40

0.34 fl. oz. / 10 ml.

INGREDIENTS AND APPEARANCE

LIP SCREEN BROAD SPECTRUM SPF 40 
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)
VANILLIN (UNII: CHI530446X)
2-METHYLBUTYRIC ACID (UNII: PX7ZNN5GXK)
SESAME OIL (UNII: QX10HYY4QV)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
STEVIOSIDE (UNII: 0YON5MXJ9P)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
SOYBEAN OIL (UNII: 241ATL177A)
BENZALDEHYDE (UNII: TA269SD04T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYL ACETATE (UNII: 76845O8NMZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYESTER-7 (UNII: 0841698D2F)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)
2-HEXENAL, (2E)- (UNII: 69JX3AIR1I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-257-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/22/2020

Labeler - Taylor James, Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company, Inc.		620899877	manufacture(75936-257)