TRADER JOES LIP BALM SPF 30- avobenzone, homosalate, octisalate, octocrylene lipstick

TRADER JOES LIP BALM by

Drug Labeling and Warnings

TRADER JOES LIP BALM by is a Otc medication manufactured, distributed, or labeled by Trader Joe's Company, Port Jervis Laboratories, Inc., Port Jervis Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

SUNSCREEN

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.

ACTIVE INGREDIENT

AVOBENZONE 3.0%

HOMOSALATE 7.0%

OCTISALATE 4.5%

OCTOCRYLENE 9.0%

WARNINGS

For external use only.

Flammable. Keep away from heat or flame.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

• Apply liberally and generously 15 minutes before sun exposure.
• Reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours.
• Children under 6 months: 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 15 value or higher along with 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.

OTHER INFORMATION

• Protect this product from excessive heat and direct sun
• Do not store below 15°C (60°F).

INACTIVE INGREDIENTS

BEESWAX, OCTYLDODECANOL, BUTYLOCTYL SALICYLATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, OCTYLDODECYL NEOPENTANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PUNICA GRANATUM STEROLS, TOCOPHERYL ACETATE, FLAVOR (AROMA), RUBUS IDAEUS (RASPBERRY) SEED OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, SODIUM HYALURONATE, HYDROGENATED CASTOR OIL

QUESTIONS?

1- 626-599-3700 Monday – Friday 9 AM – 5 PM PST

4.8 PDP

4.8 Carton

INGREDIENTS AND APPEARANCE

TRADER JOES LIP BALM  SPF 30
avobenzone, homosalate, octisalate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71270-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PUNICA GRANATUM STEROLS (UNII: UKV92KC49T)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
BEESWAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71270-158-02	1 in 1 CARTON	01/15/2025
1	NDC: 71270-158-01	4.8 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2025

Labeler - Trader Joe's Company (006226666)

Registrant - Port Jervis Laboratories, Inc. (001535103)

Establishment
Name	Address	ID/FEI	Business Operations
Port Jervis Laboratories, Inc		001535103	manufacture(71270-158)