SUNSCREEN WITH MOISTURIZER SPF-30- avobenzone, homosalate, octinoxate, octisalate lotion

SUNSCREEN WITH MOISTURIZER by

Drug Labeling and Warnings

SUNSCREEN WITH MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by SkinClinical AI, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE  7.5%

HOMOSALATE  6.0%

oCTISALATE  4.0%

aVOBENZONE  3.0%

PURPOSE

SUNSCREEN

USE

Helps prevent sunburn. If used with other sun protection measures (see Directions) decreases the chances of skin cancer and early signs of skin aging caused by the sun.

Warnings

For External Use Only. Do not use on damaged or broken skin.

When using this product keep away from eyes. If contact occurs, rinse with water to remove. Stop use and ask doctor if rash develops.

OTHER INFORMATION

Keep tightly closed. Protect from excessive heat (40°/140°F) and sun. May stain some fabrics.

STOP USE

Stop use and ask a doctor if irritation or sensitivity develops.

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.

DIRECTIONS

Apply generously 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating immediately after towel drying. Sun protection measures: Spending time in the sun increases your chances of skin cancer and early signs of aging. To decrease this risk, regularly use a sunscreen with SPF protection value 15 or higher and other sun protection measures including limited time in the sun, especially between the hours of 10am -2pm, wear long-sleeved shirt, pants, hat and sunglasses. Children under 6 months of age, consult a doctor before use.

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glycerin, Diethylhexyl 2,6-Naphthalate, Silica, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, PEG-12/SMDI Copolymer, Sorbitan Stearate, Phenoxyethanol, Ethylhexylglycerin, Xanthan Gum, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil

Questions?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN WITH MOISTURIZER  SPF-30
avobenzone, homosalate, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73110-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73110-106-11	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/16/2019

Labeler - SkinClinical AI, LLC (116981342)

Registrant - SkinClinical AI, LLC (116981342)