NDC | 49967-643-01, 49967-643-02 |
Set ID | ef0c7c0d-7b83-400e-aa06-9586ddc57160 |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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
-
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?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 BUTTERSTICK LIP TREATMENT BROAD SPECTRUM SPF 25 SUNSCREEN
avobenzone, octinoxate and octocrylene lipstickProduct 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)