PLAY SPF 30 LIP SHIELD COCONUT- avobenzone, homosalate, octisalate, octocrylene gel

PLAY SPF 30 Lip Shield Coconut by

Drug Labeling and Warnings

PLAY SPF 30 Lip Shield Coconut 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%, Homosalate 10%, Octisalate 5%, Octocrylene 10% .... Purpose Sunscreen

PURPOSE

Uses Helps prevent sunburn

• If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer acn 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

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

Apply generously and evenly 15 minutes before sun exposure.

• reapply: after 80 minutes of swimming or sweating.
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures: Spending time in the sun increases your skin 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

INACTIVE INGREDIENT

Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelila) Wax, Flavor (Coconut), Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Ozokeite Wax, Persea Gratissima (Avocado) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Stevia Rebaudiana Extract, Tocopherol, Vitis Vinifera (Grape) Seed Oil

STORAGE AND HANDLING

Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Supergoop!

PLAY

SPF 30

Lip Shield

Coconut

Broad Spectrum Sunscreen SPF 30

Water & Sweat Resistant

(80 minutes)

0.15 oz. / 4.25 g.

INGREDIENTS AND APPEARANCE

PLAY SPF 30 LIP SHIELD COCONUT 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-156
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 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERESIN (UNII: Q1LS2UJO3A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ROSEMARY (UNII: IJ67X351P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-156-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	10/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/02/2020

Labeler - Supergoop, LLC (117061743)