Label: AQUAPHOR LIP PROTECTANT AND SUNSCREEN- petrolatum, avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 10356-111-23, 10356-111-30, 10356-111-40
- Packager: Beiersdorf Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
•temporarily protects and helps relieve chapped or cracked lips
•helps protect lips from the drying effects of wind and cold weather
•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 - WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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 -
INACTIVE INGREDIENT
Inactive ingredients C18-38 Alkyl Hydroxystearoyl Stearate, Octyldodecanol, Glycerin, Ricinus
Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Panthenol, Water, Polyglyceryl-3 Diisostearate,
Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Hydrogenated Castor Oil, Beeswax, C20-40 Alkyl
Stearate, Magnesium Sulfate, Magnesium Stearate, BHT. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AQUAPHOR LIP PROTECTANT AND SUNSCREEN
petrolatum, avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10356-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 31 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.75 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.4 g in 100 mL Inactive Ingredients Ingredient Name Strength OCTYLDODECANOL (UNII: 461N1O614Y) GLYCERIN (UNII: PDC6A3C0OX) CASTOR OIL (UNII: D5340Y2I9G) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) SHEA BUTTER (UNII: K49155WL9Y) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) YELLOW WAX (UNII: 2ZA36H0S2V) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) MAGNESIUM STEARATE (UNII: 70097M6I30) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10356-111-23 10 mL in 1 TUBE; Type 0: Not a Combination Product 06/30/2015 2 NDC:10356-111-30 0.9 mL in 1 PACKET; Type 0: Not a Combination Product 06/30/2015 3 NDC:10356-111-40 2 in 1 BLISTER PACK 06/30/2015 3 NDC:10356-111-23 10 mL 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 Drug M016 06/30/2015 Labeler - Beiersdorf Inc (001177906)
