Sunscreen Karina Skin Care Moist: Package Insert and Label Information

SUNSCREEN KARINA SKIN CARE MOIST- zinc oxide and octinoxate emulsion
CA-Botana International

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 Ingredient

Octinoxate 7.5%………………………………………Sunscreen

Zinc Oxide 7.0%……………………………………… Sunscreen

Purpose

Sunscreen

Ask Doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children

Inactive Ingredients

Water (Aqua), Glycerine, Cetearyl isononanoate, Coco caprylate caprate, Prunus amygdalus dulcis (Sweet Almond) oil, Caprylic/Capric triglyceride, Cetyl alcohol, Propanediol, Aloe barbadensis leaf extract, Ascorbic acid, Ascorbyl palmitate, Olea europaea (Olive) leaf , Potassium sorbate, Rosmarinus officinalis (Rosemary) leaf, Tocopherol, Xanthan gum, Citric acid, Ethylhexylglycerin, Phenoxyethanol, Acrylates C10-30 Alkyl Acrylate Crosspolymer,Alpha Acetyl Tetrapeptide — 5, Butyloctyl Salicylate, Camellia sinensis (White tea) Leaf extract, Cetearyl Alcohol, Ceteareth-20, Chamomillla recutita (Matricaria)Flower extract, Emulsifying wax, Ethyl Ferulate, Euterpe Oleracea (Acai) Fruit extract, Ginkgo Biloba leaf extract, Juniperus communis (Juniper) Fruit, Malpighia punicifolia (Acerola) Fruit extract, Simmondsia chinensis (Jojoba) Seed oil, Sodium Phytate. Tocopheryl Acetate, Triethoxycaprylylsilane.

Safety information

Protect this product from excessive heat and direct sun

Dosage & Administration

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. 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 of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct 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. If product is swallowed get medical help or contact a poison Control Center right away.

Indications & Usage

Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

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SUNSCREEN KARINA SKIN CARE MOIST
octinoxate, zinc oxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-033
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 9.919 g in 141.7 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 10.62 g in 141.7 g
Inactive Ingredients
Ingredient Name Strength
BUTYLOCTYL SALICYLATE
MATRICARIA RECUTITA FLOWERING TOP
JUNIPERUS COMMUNIS STEM
ROSEMARY
HEXASODIUM PHYTATE
POLAWAX POLYSORBATE
ACEROLA
PHENOXYETHANOL
ACETYL TETRAPEPTIDE-5
ASCORBYL PALMITATE
WHITE TEA
ALLANTOIN
OLIVE OIL
ETHYL FERULATE
ACAI
GINKGO BILOBA ROOT
JOJOBA OIL
TOCOPHEROL
XANTHAN GUM
POTASSIUM SORBATE
CETEARYL ISONONANOATE
GLYCERIN
ALOE VERA LEAF
CETYL ALCOHOL
PROPANEDIOL
ETHYLHEXYLGLYCERIN
ASCORBIC ACID
WATER
CETEARETH-22
ANHYDROUS CITRIC ACID
COCO-CAPRYLATE/CAPRATE
TRIETHOXYCAPRYLYLSILANE
CETOSTEARYL ALCOHOL
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE)
ALPHA-TOCOPHEROL ACETATE
ALMOND OIL
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
Product Characteristics
Color white (white yellowish) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35192-033-16 141.7 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/30/2021
Labeler — CA-Botana International (106276728)
Establishment
Name Address ID/FEI Operations
CA-Botana International 106276728 manufacture (35192-033)

Revised: 04/2021 CA-Botana International

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