Label: CHAPSTICK- avobenzone, octinoxate, and white petrolatum kit
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Contains inactivated NDC Code(s)
NDC Code(s): 0573-2028-02 - Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Moisturizer | Original
Uses
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- helps prevent sunburn
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- 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
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- helps prevent and temporarily protects chafed, chapped or cracked lips
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- helps prevent and protect from the drying effects of wind and cold weather
Directions
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- apply liberally 15 minutes before sun exposure
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- reapply at least every 2 hours
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- use a water resistant sunscreen if swimming or sweating
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- children under 6 months of age: Ask a doctor
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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:
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- limited time in the sun, especially from 10 a.m. – 2 p.m.
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- wear long-sleeved shirts, pants, hats, and sunglasses
Other information
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- store at 20-25°C (68-77°F)
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- protect this product from excessive heat and direct sun
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Classic | Original . Cherry . Strawberry
Uses
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- helps prevent and temporarily protects chafed, chapped or cracked lips
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- helps prevent and protect from the drying effects of wind and cold weather
Inactive ingredients (Classic Original)
arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium dioxide, white wax, yellow 5 lake
- Additional Information
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PRINCIPAL DISPLAY PANEL
NDC 0573-2028-02
ChapStick®
PUT YOUR LIPS FIRST®
8 HOUR MOISTURE
SPF15
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- 9 Classic Cherry/Skin Protectant
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- 9 Classic Original/Skin Protectant
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- 9 Classic Strawberry/Skin Protectant
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- 9 Moisturizer Original Skin/Sunscreen/Broad Spectrum SPF 15
NET WT 0.15 OZ
(4 g) EACH72 INDIVIDUAL STICKS
PAA171900 – Front Carton
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INGREDIENTS AND APPEARANCE
CHAPSTICK
avobenzone, octinoxate, and white petrolatum kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2028 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-2028-02 1 in 1 PACKAGE; Type 0: Not a Combination Product 06/28/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 18 CYLINDER 72 g Part 2 18 CYLINDER 72 g Part 3 18 CYLINDER 72 g Part 4 18 CYLINDER 72 g Part 1 of 4 CHAPSTICK MOISTURIZER ORIGINAL
avobenzone, octinoxate, and white petrolatum stickProduct Information 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 75 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 423 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARNAUBA WAX (UNII: R12CBM0EIZ) CETYL ALCOHOL (UNII: 936JST6JCN) ISOCETYL STEARATE (UNII: 3RJ7186O9W) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) SACCHARIN (UNII: FST467XS7D) .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 final part347 06/28/2021 Part 2 of 4 CHAPSTICK CLASSIC STRAWBERRY
white petrolatum stickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 450 mg in 1 g Inactive Ingredients Ingredient Name Strength ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARNAUBA WAX (UNII: R12CBM0EIZ) CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) LEMON OIL (UNII: I9GRO824LL) LIGHT MINERAL OIL (UNII: N6K5787QVP) MALTOL (UNII: 3A9RD92BS4) OCTYLDODECANOL (UNII: 461N1O614Y) PARAFFIN (UNII: I9O0E3H2ZE) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) D&C RED NO. 6 (UNII: 481744AI4O) SACCHARIN (UNII: FST467XS7D) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 final part347 06/28/2021 Part 3 of 4 CHAPSTICK CLASSIC CHERRY
white petrolatum stickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 450 mg in 1 g Inactive Ingredients Ingredient Name Strength ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARNAUBA WAX (UNII: R12CBM0EIZ) CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) LEVOMENTHOL (UNII: BZ1R15MTK7) OCTYLDODECANOL (UNII: 461N1O614Y) PARAFFIN (UNII: I9O0E3H2ZE) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) D&C RED NO. 6 (UNII: 481744AI4O) SACCHARIN (UNII: FST467XS7D) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 final part347 04/30/2021 Part 4 of 4 CHAPSTICK CLASSIC ORIGINAL
white petrolatum stickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 450 mg in 1 g Inactive Ingredients Ingredient Name Strength ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARNAUBA WAX (UNII: R12CBM0EIZ) CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) OCTYLDODECANOL (UNII: 461N1O614Y) OLEYL ALCOHOL (UNII: 172F2WN8DV) PARAFFIN (UNII: I9O0E3H2ZE) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) D&C RED NO. 6 (UNII: 481744AI4O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WHITE WAX (UNII: 7G1J5DA97F) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 final part347 04/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/28/2021 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
