MedPath

PLAY Lip Shield SPF 30 - Mint

PLAY Lip Shield SPF 30 - Mint

Approved
Approval ID

3cab1a7d-6226-9eba-e063-6294a90a8c4d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 18, 2025

Manufacturers
FDA

Supergoop LLC

DUNS: 117061743

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate, Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75936-658
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 18, 2025
FDA Product Classification

INGREDIENTS (18)

AVOBENZONEActive
Quantity: 3 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
OCTISALATEActive
Quantity: 5 g in 100 g
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 10 g in 100 g
Code: 5A68WGF6WM
Classification: ACTIB
COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Code: 724GKU717M
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
STEVIA REBAUDIANA LEAFInactive
Code: 6TC6NN0876
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
MENTHA PIPERITAInactive
Code: 79M2M2UDA9
Classification: IACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OILInactive
Code: 8LGU7VM393
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OILInactive
Code: 3W1JG795YI
Classification: IACT
HOMOSALATEActive
Quantity: 10 g in 100 g
Code: V06SV4M95S
Classification: ACTIB
PERSEA GRATISSIMA (AVOCADO) OILInactive
Code: 6VNO72PFC1
Classification: IACT
VITIS VINIFERA (GRAPE) SEED OILInactive
Code: 930MLC8XGG
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/18/2025

PLAY

SPF 30

Lip Shield

Mint

Broad Spectrum

Sunscreen SPF 30

Water & Sweat Resistant

(80 minutes)

0.15 oz. / 4.25 g. Back Label

Front Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/18/2025

Stop use and ask a doctor if rash occurs

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/18/2025

**Active Ingredients:**Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/18/2025

Helps prevent sunburn

If used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

LOINC: 34071-1Updated: 8/18/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/18/2025

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/18/2025

Directions

• Apply generously and evenly as the last step in your skincare routine, before makeup and 15 minutes before sun exposure. • Reapply: • after 80 minutes of swimming or sweating. • immediately after towel drying • at least every 2 hours. • Children under 6 months of age: ask a doctor. •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 time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/18/2025

**Inactive Ingredients:**Cocos Nucifera (Coconut) Oil, Ozokerite wax, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Tocopherol, Glycine Soja (Soybean) Oil, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Piper Mentha Piperita (Natural Flavor), Stevia Rebaudiana Extract, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Oil, Vitis Vinifera (Grape) Seed Oil

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