FDA.reportPublic FDA data

Sonage Protec Plus SPF 30 Mineral Sunscreen

Manufacturer
ASA Universal Inc. dba: Sonage
Effective date
2026-08-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:01:06

Label at a glance#

ProductSonage Protec Plus SPF 30 Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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.

Dosage and administration

• Apply liberally 15 minutes before sun exposure. • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying • Reapply at least every 2 hours. • Children under 6 months: 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 h...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.7%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eye. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating
  • Reapply immediately after towel drying
  • Reapply at least every 2 hours.
  • Children under 6 months: 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 and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bisabolol* , butyloctyl salicylate, butyrospermum parkii (shea) butter*, caprylhydroxamic acid, capryloyl glycerin/sebacic acid copolymer, caprylyl glycol, cellulose gum, cetearyl alcohol, cetyl alcohol, citric acid, coco-glucoside, cocos nucifera (coconut) oil, diheptyl succinate, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodium hyaluronate, sodium stearoyl glutamate, theobroma cacao (cocoa) seed butter*, tocopherol, water
*certified organic

Other Information:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

Package/Label Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SONÄGE®
 
PROTEC PLUS
MINERAL
SUNSCREEN
Broad Spectrum SPF 30
 
WATER RESISTANT
(80 minutes)
 
COCOA BUTTER
HYALURONIC ACID
BISABOLOL
℮ 50 ml. / 1.69 fl. oz
THE NEW NATURAL®
 
 
Made in the USA from responsibly sourced
domestic and global ingredients.
 
Dist. by/par Sonäge, Santa Monica,
CA 90405 U.S.A
sonage.com

Image-Carton
Image-Carton

Package/Label Principal Display Panel – 50 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SONÄGE®
 
PROTEC PLUS
MINERAL
SUNSCREEN
Broad Spectrum SPF 30
 
WATER RESISTANT
(80 minutes)
 
COCOA BUTTER
HYALURONIC
BISABOLOL
℮ 50 ml. / 1.7 fl. oz
THE NEW NATURAL®
 
 
Made in the USA from responsibly sourced
domestic and global ingredients.
 
Dist. by/par Sonäge, Santa Monica, CA 90405 U.S.A
sonage.com

image-50v
image-50v

Package/Label Principal Display Panel – 30 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SONÄGE®
 
PROTEC PLUS
MINERAL
SUNSCREEN
Broad Spectrum SPF 30
 
WATER RESISTANT
(80 minutes)
 
COCOA BUTTER
HYALURONIC ACID
BISABOLOL
℮ 30 ml. / 1 fl. oz
THE NEW NATURAL®
 
 
Made in the USA from responsibly sourced domestic and global ingredients.
 
Dist. by/par Sonäge, Santa Monica, CA 90405 U.S.A
sonage.com

image-30
image-30

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130851750001959GTIN-13: 0851750001959
EAN-13: 0851750001959
GTIN-12: 851750001959
UPC-A: 851750001959
GTIN storage (14 digits): 00851750001959		image-50.jpeg.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69546-32269546-322-02, 69546-322-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO-GLUCOSIDEICS790225BIACT
COCONUT OILQ9L0O73W7LIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SODIUM GLUCONATER6Q3791S76IACT
HYALURONATE SODIUMYSE9PPT4THIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
DOCOSANOL9G1OE216XYIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
COCOA BUTTER512OYT1CRRIACT
WATER059QF0KO0RIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-12-20full-release2026-06-01 00:47:57

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sonage Protec Plus SPF 30 Mineral SunscreenZINC OXIDEASA Universal Inc. dba: Sonaged92fc1df-bbeb-592a-e053-2a95a90a69512026-08-12WarningsExact identifier
ndc (package): 69546-322-02
ndc (package): 69546-322-30
ndc (product): 69546-322
ndc11 (package): 69546032230
ndc11 (package): 69546032202
spl id: ee78d102-f2aa-4b45-aa66-366819356901
spl set id: d92fc1df-bbeb-592a-e053-2a95a90a6951

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.