SERUM CREMA BROAD SPECTRUM SPF20 SUNSCREEN- zinc oxide lotion

Serum Crema by

Drug Labeling and Warnings

Serum Crema by is a Otc medication manufactured, distributed, or labeled by Pure on Purpose, LLC, Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide (non-nano uncoated) 13.5%

Purpose

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

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.

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 & other sun protection measures including:
  • limit time in the sun, especially from 10am–2pm
  • wear long-sleeved shirts, pants, hats & sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours

OTHER INFORMATION

Protect this product from excessive heat & direct sunlight.

INACTIVE INGREDIENTS

Argania Spinosa Kernel Oil* (Argan), Camellia Sinensis (Green Tea) Seed Oil*, Carthamus Tinctorius (Safflower) Seed Oil*, Cera Alba (Beeswax)*, Glycerin*, Glycyrrhiza Glabra (Licorice) Root Extract, Haematococcus Pluvialis Extract (Astaxanthin derived from Plankton), Helianthus Annuus (Sunflower) Seed Oil*, Iron Oxides (CI 77491) & (CI 77492), Jojoba Esters, Persea Gratissima (Avocado) Oil*, Prunus Armeniaca (Apricot) Kernel Oil*, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopherol (Vitamin E). *denotes certified organic

Package/Label Principal Display Panel

VIVE SANA
ORGANIC SUNCARE

SERUM CREMA
PREPARE-DEEPLY NOURISHING ARGAN
PROTECT-NON-NANO UNCOATED ZINC
REBUILD-GREEN TEA & RED RASPBERRY
IMPROVE-PLANKTON & LICORICE ROOT
BROAD SPECTRUM
-SPF 20-
SHEER BRIGHTENING FINISH
100% NATURAL

NET WEIGHT 2 FL. OZ / 59 ML

Label

INGREDIENTS AND APPEARANCE

SERUM CREMA  BROAD SPECTRUM SPF20 SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71556-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ROSEMARY (UNII: IJ67X351P9)
RASPBERRY SEED OIL (UNII: 9S8867952A)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71556-200-01	1 in 1 CARTON	07/10/2017
1		59 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	07/10/2017

Labeler - Pure on Purpose, LLC (080668430)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(71556-200)