PROTEC PLUS NATURAL SPF 30- zinc oxide cream
ASA Universal Inc. dba: SONAGE

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.

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Sonage Protec Plus Natural SPF 30

Active ingredient

Zinc Oxide 13.5%

Purpose

Sunscreen

Uses

Used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by the sun. Helps prevent sunburn and photodamage.

Warnings

For external use only. Keep product out of eyes. Rinse with water to remove.

Stop Use

and ask a doctor if continuous rash/irritation develops.

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Do Not Use

on broken skin.

Directions

Allow product to absorb before applying make-up. Product should be patted on, not rubbed in. Apply 15 minutes before sun exposure and reapply every 2 hours. Using a water resistant sunscreen if swimming or sweating. To decrease risk of skin cancer and early skin aging, use sunscreen products with a minimum SPF of 15. Children under 6 months of age: ask a doctor.

Inactive Ingredients

Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccana Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Santalum Album (Sandalwood) Extract, Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Phellodendron Amurense Bark Extract, Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Sodium Hydroxide, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid

Package/Label Principal Display Panel

SONAGE®

PROTEC Plus
NATURAL SPF 30
Broad Spectrum UVA/UVB

net 50 ml. e 1.7 fl. oz.

•: Light weight mineral sunscreen without toxic chemicals
•: Red Algae provides super protection without whitish look
•: Macadamia, Sandlewood, Barley prevent premature aging

Label

PROTEC PLUS NATURAL SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69546-312
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
KUKUI NUT OIL (UNII: TP11QR7B8R)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WITCH HAZEL (UNII: 101I4J0U34)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
SANDALWOOD (UNII: 3641YW25N2)
BARLEY (UNII: 5PWM7YLI7R)
MACADAMIA OIL (UNII: 515610SU8C)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
MALIC ACID (UNII: 817L1N4CKP)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LACTATE (UNII: TU7HW0W0QT)
FYTIC ACID (UNII: 7IGF0S7R8I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69546-312-01	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/15/2016	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/15/2016	12/31/2021

Labeler - ASA Universal Inc. dba: SONAGE (054687895)

Revised: 1/2022

Document Id: ae08cc74-8bda-4e7a-b260-110af3fcb17a

Set id: ddacc736-bab3-4690-9f8b-1d1cb53eb521

Version: 4

Effective Time: 20220104

ASA Universal Inc. dba: SONAGE