FDA.reportPublic FDA data

CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15

Manufacturer
MANA PRODUCTS, INC. | MANA PRODUCTS, INC
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:35

Label at a glance#

ProductCHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Dosage and administration

Apply evenly before sun exposure. Children under 6 months of age: ask a doctor. Reapply as needed or after towel drying, swimming or sweating.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.5%
Zinc Oxide 2.97%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

OTC - WHEN USING SECTION

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Warnings

WARNINGS SECTION

For external use only.

When using this product:

keep out of eyes. Rinse with water to remove.

Stop use and see a doctor if

rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply evenly before sun exposure. Children under 6 months of age: ask a doctor. Reapply as needed or after towel drying, swimming or sweating.

Other Information

OTHER SAFETY INFORMATION

Moderate sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, (AQUA), ISODODECANE, OCTYLDODECYL NEOPENTANOATE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, POLYGLYCERYL-4 ISOSTEARATE, DIMETHICONE CROSSPOLYMER, SILICA, NYLON-12, TALC, DIMETHICONE CROSSPOLYMER-3, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, PEG/PPG 18/18 DIMETHICONE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, TRIETHOXYCAPRYLYLSILANE, POLYDODECANAMIDEAMINIUM TRIAZADIPHENYLETHENESULFONATE, POLYVINYLALCOHOL CROSSPOLYMER, PROPYLENE CARBONATE, CHONDRUS CRISPUS (CARRAGEENAN), XANTHAN GUM, ALOE BARBADENSIS LEAF EXTRACT, PHYTANTRIOL, RETINYL PALMITATE, TOCOPHEROL, TETRAHEXYLDECYL ASCORBATE, SODIUM HYALURONATE, SODIUM DEHYDROACETATE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, STEARIC ACID, ALUMINUM HYDROXIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, ZINC CHLORIDE, LYSINE, MICA (CI 77019), IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

RECENT MAJOR CHANGES SECTION

Dosage & Admin update

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-500-01CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 1530 g in 1 TUBECREAM302
59735-500-01CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 151 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-500CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 CREAM [MANA PRODUCTS, INC.]2Legacy NDC, 2 package rows20240104_ea9e303f-3963-5fa2-e053-2995a90a07ff.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-50059735-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHYTANTRIOL8LVI07A72WIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TOCOPHEROLR0ZB2556P8IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLPARABENZ8IX2SC1OHIACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
TALC7SEV7J4R1UIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
HEXYL LAURATE4CG9F9W01QIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
NYLON-12446U8J075BIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CARRAGEENAN5C69YCD2YJIACT
LYSINEK3Z4F929H6IACT
MICAV8A1AW0880IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
PROPYLENE CARBONATE8D08K3S51EIACT
XANTHAN GUMTTV12P4NEEIACT
ALOE VERA LEAFZY81Z83H0XIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
METHYLPARABENA2I8C7HI9TIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
ZINC CHLORIDE86Q357L16BIACT

Source Document#

Source XML

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
0e11f733-450f-4dda-e063-6294a90a0f89ea9e303f-3963-5fa2-e053-2995a90a07ff2024-01-03WarningsExact identifier
spl id: 0e11f733-450f-4dda-e063-6294a90a0f89
spl set id: ea9e303f-3963-5fa2-e053-2995a90a07ff

Reported adverse events (FAERS/openFDA)#

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