AVEENO ULTRA CALMING DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate lotion

Aveeno Ultra Calming Daily Moisturizer Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Aveeno Ultra Calming Daily Moisturizer Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone (3%)	Sunscreen
Octinoxate (7.5%)	Sunscreen
Octisalate (2%)	Sunscreen

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

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 and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

For sunscreen use:

• apply generously and evenly 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

• protect this product from excessive heat and direct sun
• may stain some fabrics

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Dimethicone, Cyclopentasiloxane, Glycerin, Arachidyl Alcohol, Phenyl Trimethicone, Phenoxyethanol, Cyclohexasiloxane, Cetearyl Glucoside, Benzyl Alcohol, Panthenol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Sodium Cocoyl Amino Acids, Polyacrylamide, Fragrance, Steareth-21, Arachidyl Glucoside, Disodium EDTA, Methylparaben, C13-14 Isoparaffin, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sarcosine, Laureth-7, Potassium Aspartate, Magnesium Aspartate

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

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Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

DERMATOLOGIST RECOMMENDED

Aveeno®

ULTRA-
CALMING

daily
moisturizer
sunscreen

BROAD SPECTRUM
SPF15

visibly reduces the look
of redness in 1 week

MOISTURIZE

4.0 fl oz (120 mL)

INGREDIENTS AND APPEARANCE

AVEENO ULTRA CALMING DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0468
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 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Dimethicone (UNII: 92RU3N3Y1O)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Glycerin (UNII: PDC6A3C0OX)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Benzyl Alcohol (UNII: LKG8494WBH)
Panthenol (UNII: WV9CM0O67Z)
Acrylic Acid/Ethylene Copolymer (600 MPA.S) (UNII: 1PEZ3NLY6I)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Steareth-21 (UNII: 53J3F32P58)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Methylparaben (UNII: A2I8C7HI9T)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Feverfew (UNII: Z64FK7P217)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Sarcosine (UNII: Z711V88R5F)
Laureth-7 (UNII: Z95S6G8201)
Potassium Aspartate (UNII: OC4598NZEQ)
Magnesium Aspartate (UNII: R17X820ROL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0468-4	1 in 1 CARTON	02/01/2018
1		120 mL in 1 BOTTLE; 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	02/01/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)