KIEHLS SINCE 1851 BUTTERSTICK LIP TREATMENT BROAD SPECTRUM SPF 25 SUNSCREEN- avobenzone, octinoxate and octocrylene lipstick

Kiehls Since 1851 Butterstick Lip Treatment Broad Spectrum SPF 25 Sunscreen by

Drug Labeling and Warnings

Kiehls Since 1851 Butterstick Lip Treatment Broad Spectrum SPF 25 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc., Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Octinoxate 6%

Octocrylene 6%

Purpose

Sunscreen

Use

helps prevent sunburn

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.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

●  apply liberally 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 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

Other information

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

Inactive ingredients

cocos nucifera (coconut) oil, helianthus annuus (sunflower) seed oil, beeswax, euphorbia cerifera (candelilla) wax, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, hydrogenated coco-glycerides, copernicia cerifera (carnauba) wax, garcinia indica seed butter, squalane, limnanthes alba (meadowfoam) seed oil, hydrogenated vegetable oil, citrus limon (lemon) peel oil, prunus amygdalus dulcis (sweet almond) oil, limonene, tocopherol, ximenia americana seed oil, citrus medica limonum (lemon) peel extract, stevia rebaudiana extract, alumina, PEG-8, lauroyl lysine, glycine soja (soybean) oil, citral, ascorbyl palmitate, citric acid, ascorbic acid, may contain: titanium dioxide, mica, iron oxides, red 27 lake, red 30 lake, red 7 lake, red 33 lake, barium sulfate, yellow 5 lake

Questions or comments?

Call toll free 1-800-946-4453

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INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 BUTTERSTICK LIP TREATMENT BROAD SPECTRUM SPF 25 SUNSCREEN 
avobenzone, octinoxate and octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-643
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
SQUALANE (UNII: GW89575KF9)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
LEMON OIL (UNII: I9GRO824LL)
ALMOND OIL (UNII: 66YXD4DKO9)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TOCOPHEROL (UNII: R0ZB2556P8)
XIMENIA AMERICANA SEED (UNII: 9WJ8WS9R1L)
LEMON PEEL (UNII: 72O054U628)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
LAUROYL LYSINE (UNII: 113171Q70B)
SOYBEAN OIL (UNII: 241ATL177A)
CITRAL (UNII: T7EU0O9VPP)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BARIUM SULFATE (UNII: 25BB7EKE2E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-643-01	1 in 1 CARTON	11/01/2016
1		4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-643-02	2 in 1 CARTON	11/01/2016
2		4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-643)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(49967-643)