SKINMEDICA TNS ULTIMATE DAILY MOISTURIZER SUNSCREEN SPF 20- octinoxate, zinc oxide cream

SkinMedica TNS Ultimate Daily Moisturizer Sunscreen SPF 20 by

Drug Labeling and Warnings

SkinMedica TNS Ultimate Daily Moisturizer Sunscreen SPF 20 by is a Otc medication manufactured, distributed, or labeled by Allergan, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%

Zinc Oxide 5.3%

Purpose

Sunscreen

Sunscreen

Use

• 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 or irritation develops and lasts.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
• 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
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.

Other information

• Protect the product in this container from excessive heat and direct sun.
• Store at room temperature 15° - 30°C (59° - 86°F).

Inactive ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Squalane, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Human Fibroblast Conditioned Media, Saccharomyces Ferment Lysate Filtrate, Ubiquinone, Pikea Robusta Extract, Ceramide NP, Butyrospermum Parkii (Shea Butter), Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Tocopherol, Panthenol, Glycine Soja (Soybean) Extract, Butylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylate-13, Polyisobutene, Polysorbate 20, Isoceteth-20, Xanthan Gum, Ethoxydiglycol, Triethoxycaprylylsilane, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben

PRINCIPAL DISPLAY PANEL

SkinMedica®

TNS Ultimate Daily Moisturizer™

Broad Spectrum
SPF 20

Hydrates and helps fight environmentally-induced skin aging with TNS®, patented growth factor blend, antioxidants and broad spectrum UVA/UVB protection.

Sunscreen

MOISTURIZE

Net Wt. 56.7 g / 2 Oz.

INGREDIENTS AND APPEARANCE

SKINMEDICA TNS ULTIMATE DAILY MOISTURIZER SUNSCREEN SPF 20 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-4953
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	75 mg  in 1 g
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	53 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)
squalane (UNII: GW89575KF9)
dimethicone (UNII: 92RU3N3Y1O)
glyceryl monostearate (UNII: 230OU9XXE4)
PEG-100 stearate (UNII: YD01N1999R)
glycerin (UNII: PDC6A3C0OX)
saccharomyces lysate (UNII: R85W246Z1C)
ubidecarenone (UNII: EJ27X76M46)
pikea robusta (UNII: 1HL404JO0I)
ceramide 3 (UNII: 4370DF050B)
shea butter (UNII: K49155WL9Y)
green tea leaf (UNII: W2ZU1RY8B0)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)
panthenol (UNII: WV9CM0O67Z)
soybean (UNII: L7HT8F1ZOD)
butylene glycol (UNII: 3XUS85K0RA)
cetostearyl alcohol (UNII: 2DMT128M1S)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
polyisobutylene (35000 MW) (UNII: 98553S1MHQ)
polysorbate 20 (UNII: 7T1F30V5YH)
isoceteth-20 (UNII: O020065R7Z)
xanthan gum (UNII: TTV12P4NEE)
diethylene glycol monoethyl ether (UNII: A1A1I8X02B)
triethoxycaprylylsilane (UNII: LDC331P08E)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
propylparaben (UNII: Z8IX2SC1OH)
isobutylparaben (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-4953-13	12 in 1 CARTON	01/01/2013
1		3.7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0023-4953-02	1 in 1 CARTON	01/01/2013
2		56.7 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 NOT FINAL	part352	01/01/2013

Labeler - Allergan, Inc. (144796497)