Daily Facial Moisturizer SPF 35: Package Insert and Label Information

DAILY FACIAL MOISTURIZER SPF 35- octinoxate and avobenzone lotion
Pharmco Laboratories 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.

Drug Facts

Active Ingredient: Purpose
Avobenzone 2.5% Sunscreen
Octinoxate 4% Sunscreen

Uses

  • Helps prevent sunburn.

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 product is swallowed, get medical help or contact Poison Control Center right away.

Directions

  • After cleansing apply evenly to face and neck every morning, at least 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours or after sweating.
  • Children under 6 months of age: Ask a doctor. (Not intended for use on children)

Other Ingredients

Water, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, C13-14 Isoparrafin, Laureth 7, Polyacrylamide, Benzyl Alcohol, Fragrance, Sodium Hydroxide, Methylisothiazolinone, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Citric Acid

Skin Cancer/Skin Aging Alert & 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

This product has been shown to help prevent sun burn, not skin cancer or early skin aging.

Other Information

Store at 15-30°C (59-86°F). Protect the product in this container from excessive heat and or freezing conditions.

Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780
www.pharmcolabs.com • 1.800.635.0712 • Reorder CPL16-3

PRINCIPAL DISPLAY PANEL — 87 g Tube Label

PHARMCO
SKINCARE LABS

Daily Facial Moisturizer

Broad Spectrum SPF 30+

Net wt. 3 oz. (87 g)

PRINCIPAL DISPLAY PANEL -- 87 g Tube Label
(click image for full-size original)
DAILY FACIAL MOISTURIZER SPF 35
octinoxate and avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58400-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 40 mg in 1 g
Avobenzone (Avobenzone) Avobenzone 25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Aloe
Benzyl Alcohol
Carthamus Tinctorius Seed Oleosomes
Alkyl (C12-15) Benzoate
C13-14 Isoparaffin
Laureth-7
Methylisothiazolinone
Sodium Hydroxide
.Alpha.-Tocopherol Acetate
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58400-007-01 87 g in 1 TUBE None
2 NDC:58400-007-02 3900 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 06/01/2012
Labeler — Pharmco Laboratories Inc. (096270814)
Establishment
Name Address ID/FEI Operations
Pharmco Laboratories Inc. 096270814 MANUFACTURE (58400-007), LABEL (58400-007), PACK (58400-007), ANALYSIS (58400-007)

Revised: 07/2020 Pharmco Laboratories Inc.

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