PLAY LIP BALM WITH ACAI BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene stick

Play Lip Balm with Acai Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Play Lip Balm with Acai Broad Spectrum SPF 30 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 Purpose

Avobenozone 3% Sunscreen

Homosalate 10% 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
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 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, Polyisobutene, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C18-38 Alkyl Hydroxystearoyl Stearate, Ozokerite, Cetyl Alcohol, Diethylhexyl 2,6-Naphthalate, Glyceryl Stearate, Polyglyceryl-10 Decaoleate, Carthamus Tinctorius (Safflower) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Trihydroxystearin, Helianthus Annuus (Sunflower) Seed Oil, Stevioside, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Tocopherol, Glycine Soja (Soybean) Oil, Euterpe Oleracea Fruit Extract, Ethyl Acetate, Gamma-Undecalactone, Vanilin

PRINCIPAL DISPLAY PANEL

Supergoop!

PLAY

SPF 30

LIP BALM with Acai

Broad Spectrum Sunscreen SPF 30

0.5 fl. oz./ 15 ml.

INGREDIENTS AND APPEARANCE

PLAY LIP BALM WITH ACAI BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-225
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ACAI (UNII: 46AM2VJ0AW)
ETHYL ACETATE (UNII: 76845O8NMZ)
SHEANUT (UNII: 84H6HBP32L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SAFFLOWER OIL (UNII: 65UEH262IS)
SESAME OIL (UNII: QX10HYY4QV)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
2-METHYLBUTYRIC ACID (UNII: PX7ZNN5GXK)
AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)
VANILLIN (UNII: CHI530446X)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW)
SUNFLOWER OIL (UNII: 3W1JG795YI)
STEVIOSIDE (UNII: 0YON5MXJ9P)
BENZALDEHYDE (UNII: TA269SD04T)
DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)
2-HEXENAL, (2E)- (UNII: 69JX3AIR1I)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-225-01	15 mL in 1 CARTON; Type 0: Not a Combination Product	02/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/27/2020

Labeler - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-225)