AQUAPHOR LIP PROTECTANT AND SUNSCREEN- petrolatum, avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion

Aquaphor Lip Protectant and Sunscreen by

Drug Labeling and Warnings

Aquaphor Lip Protectant and Sunscreen by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Petrolatum 31.0%
Avobenzone 3.0%
Octinoxate 6.75%
Octisalate 4.5%
Octocrylene 2.0%
Oxybenzone 5.4%

PURPOSE

Purpose
Skin Protectant
Sunscreen

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

Warnings
For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product avoid contact with eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if 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 right away

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

Questions

800-227-4703

PRINCIPAL DISPLAY PANEL

Aquaphor Lip Protectant + Sunscreen

Repairs and Protects

For severly dry lips

Broad Spectrum SPF 30

Immediately soothes and helps heal severely dry lips
Fragrance free and Paraben free.

Lip protectant  / Sunscreen

INGREDIENTS AND APPEARANCE

AQUAPHOR LIP PROTECTANT AND SUNSCREEN 
petrolatum, avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion

Product 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 final	part347	06/30/2015

Labeler - Beiersdorf Inc (001177906)