OTC Medication Information: Soothing Day SPF 15

SOOTHING DAY SPF 15- avobenzone, octinoxate and oxybenzone cream
Kamins Dermatologics Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients:
Avobenzone 2%

Octinoxate 7%

Octibenzone 5%

Purpose:

Sunscreen

Keep out of the reach of children.

A gentle cosmetic emollient preparation that helps moisturize dry skin conditions associated with rosacea and related couperose skin complexions. Free of fragrance, this formula contains antioxidants and soothing Bio-Maple compound to help moisturize and relieve inflammation. Also helps protect skin from UVA and UVB sun rays, which are known to be harmful to rosacea type skins. This high-performance, anti-aging daily moisturizer is a perfect primer for makeup.

Uses
■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.

Warnings
For external use only.
Avoid contact with eyes when using this product. If contact occurs, rinse abundantly with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients:

water, cetyl alcohol, PEG-100 stearate, glyceryl stearate, soluble collagen, glycerin, squalane, acer saccharum (maple isolate/isolat d’érable), PEG-16 soy sterol, ceteareth-12, diethylhexyl 2,6-naphthalate, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, xanthan gum, tocopheryl acetate, retinyl palmitate, sodium hydroxide, carbomer, phenoxyethanol, chlorphenesin.

Directions

■ Apply liberally and evenly each morning to cleansed face and neck, before sun exposure ans as needed
■ Children under 6 months of ask: ask a doctor

B. KAMINS

Soothing Day Cream SPF15

50mL / 1.7 fl.oz

DIN 02275791

Soothing Day front panel image
(click image for full-size original)

SOOTHING DAY SPF 15
avobenzone octinoxate oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-192
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 70 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE, D-
VITAMIN A PALMITATE
SODIUM HYDROXIDE
PHENOXYETHANOL
CHLORPHENESIN
WATER
CETYL ALCOHOL
POLYOXYL 100 STEARATE
GLYCERYL MONOSTEARATE
GLYCERIN
SQUALANE
ACER SACCHARUM SAP
CETETH-16
CETEARETH-12
DIETHYLHEXYL 2,6-NAPHTHALATE
QUADROSILAN
CYCLOMETHICONE 5
DIMETHICONE
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63550-192-07 50 mL in 1 BOX None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/01/2010
Labeler — Kamins Dermatologics Inc. (254050784)
Registrant — Kamins Dermatologics Inc. (254050784)
Establishment
Name Address ID/FEI Operations
Odan Laboratories Ltd 208585604 manufacture (63550-192)

Revised: 12/2022 Kamins Dermatologics Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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