FDA.reportPublic FDA data

Bali Body Sheer Glow Sunscreen SPF 50

Manufacturer
Bali Body Pty Ltd
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:13

Label at a glance#

ProductBali Body Sheer Glow Sunscreen SPF 50
Active ingredientOCTOCRYLENE, HOMOSALATE, AVOBENZONE, OCTISALATE
Label structure8 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

Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease the risk, regularly use sunscreen with broad spectrum SPF of 15 or high and other sun protection measures including: Limit time in the s...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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 eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing.
  • To decrease the risk, regularly use sunscreen with broad spectrum SPF of 15 or high and other sun protection measures including:
  • Limit time in the sun, especially between 10am - 2pm.
  • Wear a long sleeve shirt, pants, hats, and sunglasses
  • Children under 6 months of age, ask a doctor.

Other information

OTHER SAFETY INFORMATION

  • Store in a cool, dark place.
  • Keep out of direct sunlight and excessive heat.
  • Report serious adverse event to AMS Fulfilment 29010 Commerce Centre Drive, Valencia CA 91355

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cocoglycerides, Dibutyl Adipate, Dicaprylyl Carbonate, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, VP/Hexadecene Copolymer, Ethylcellulose, Mica, Fragrance (Parfum), Tocopherol, Tetramethyl Acetyloctahydronaphthalenes, Benzyl Alcohol, Vanillin, Glycine Soja (Soybean) Oil, Benzyl Salicylate, Hydroxycitronellal, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70630-0040-1Bali Body Sheer Glow Sunscreen SPF 5095 mL in 1 BOTTLE, PUMPGEL951

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-004070630-0040-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCOGLYCERIDESISE9I7DNUGIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
MICAV8A1AW0880IACT
SOYBEAN OIL241ATL177AIACT
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES2JU6ZH6GREIACT
DIBUTYL ADIPATEF4K100DXP3IACT
TOCOPHEROLR0ZB2556P8IACT
BENZYL ALCOHOLLKG8494WBHIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
CI 7789115FIX9V2JPIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
CI 774911K09F3G675IACT
AVOBENZONEG63QQF2NOXACTIB
GRAPE SEED OIL930MLC8XGGIACT
COCONUT OILQ9L0O73W7LIACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL66YXD4DKO9IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
OCTISALATE4X49Y0596WACTIB
VANILLINCHI530446XIACT

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
Bali Body Sheer Glow Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd4872793c-a7c0-1b65-e063-6394a90a8b3a2026-01-15WarningsExact identifier
ndc (package): 70630-0040-1
ndc (product): 70630-0040
ndc11 (package): 70630004001
spl id: 48726cde-43a3-c5d5-e063-6294a90a7b14
spl set id: 4872793c-a7c0-1b65-e063-6394a90a8b3a

Reported adverse events (FAERS/openFDA)#

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