AQUAPHOR LIP REPAIR STICK AND SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, stick

Aquaphor Lip Repair Stick and Sunscreen by

Drug Labeling and Warnings

Aquaphor Lip Repair Stick 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:

Avobenzone 3%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses 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 on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash 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

For sunscreen use

• apply liberally at least 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every two hours
• 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 SpectrumSPFvalue 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
Octyldodecanol, Ricinus Communis (Castor) Seed Oil, Beeswax, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea) Butter, Hydrogenated Castor OIl, Helianthus Annuus (Sunflower) Seed Wax, Cetearyl Alcohol, Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol.

QUESTIONS

Questions? 1-800-227-4703

PRINCIPAL DISPLAY PANEL

Aquaphor Lip Repair Stick

+ Sunscreen

#1 Dermatologist Recommended Lip Care Brand

Repairs and Protects

For very dry lips

Broad spectrum SPF 30

Helps relieve dryness and soothe cracked, chapped lips

With Vitamins and Shea Butter

Fragrance Free and Paraben Free

Dermatologist recommended

INGREDIENTS AND APPEARANCE

AQUAPHOR LIP REPAIR STICK AND SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10356-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SHEA BUTTER (UNII: K49155WL9Y)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10356-130-25	4.8 g in 1 TUBE; Type 0: Not a Combination Product	11/15/2021
2	NDC: 10356-130-41	2 in 1 BLISTER PACK	11/15/2021
2	NDC: 10356-130-25	4.8 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 Drug	M020	11/15/2021

Labeler - Beiersdorf Inc (001177906)